FDA Enforcement Report Week of March 26, 2014 for Drugs

Drugs	Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language)	All lots	Class I	Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient.	Fabscout Entertainment, Inc
Drugs	Silver Sword capsules, 180 mg, 16-count clamshell tin, UPC 1 234658 970128 12345 (labeling is in foreign language)	All lots	Class I	Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient.	Fabscout Entertainment, Inc
Veterinary	PURINA TEST DIET: Mod PicoLab Mouse w/12 PPM Ivermectin Route of Administration: Oral; Name and Address: Richmond Indiana Test Diet, 1050 Progress Drive, Richmond, IN 47374; Product Code 5D5R	Lot number:13JUL19RTD1	Class I	A single lot (one 3.065 kg lot) test diet product Mod PicoLab Mouse w/12 ppm Ivermectin was manufactured incorrectly. The Test Diet facility was advised by their customer of a rodent mortality incident and the on-site veterinarian diagnosed Ivermectin toxicity. Investigation confirmed that an employee manufacturing error resulted in a significantly elevated level of Ivermectin in this feed.	Land O Lakes Purina LLC
Drugs	Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30.	Lot 25-220-DD, Exp 1JAN2015	Class I	Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.	Hospira Inc.
Devices	Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx and ILDExxx***BellaTek Zirconia Abutment Position Number: XX Abutment; Pilier; Abutment; Abutment; Pilastro; Pilar***Rx only***Non-sterile, Sterilize prior to use.***Biomet 3i Dental Iberica S.L.*** Biomet 3i Dental Abutments are intended for use as accessories to endosseous dental implants to support prostheses in edentulous or partially edentulous patients. These are intended for use to support single and multiple tooth prostheses.	All lots of products made since April 1, 2011. Catalog model EDAZ, EDAZx and ILDExxx	Class II	Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received.	Biomet 3i, LLC
Food	10" Chocolate Supreme Cake Layers, NET WT. 20 oz. packed in cases of 12. Keep Frozen until ready to use. CSM Bakery Products NA, Inc., Tucker, GA 30084 USA Product is for institutional use.	Lot #1328702013 All cases stamped with Lot #1328702013 and also showing a USE BY date of JUL/14/14 along with a 24-hour time stamp between 15:00 and 24:00. For example, a case showing "1328702013 17:36 USE BY JUL/14/14" is subject to the recall while "1328702013 02:14 USE BY JUL/14/14" is not subject to the recall. Also NOT included in the recall would be a case showing an earlier USE BY date along with Lot # 1328702013. For example, "1328702013 15:36 USE BY JUL/13/14" is not subject to the recall.	Class II	Foreign Material - specifically the product has the potential to contain pieces of a red plastic scoop.	CSM Bakery Products North America
Drugs	5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product code 2B0089, NDC 0338-0017-38.	Lot #: P285288, Exp 11/13	Class I	Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution.	Baxter Healthcare Corp.
Drugs	0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX plastic containers (Product code 2B1308, NDC 0338-0049-31) and b) 100 mL Single dose VIAFLEX plastic containers (Product code 2B1302, NDC 0338-0049-18) and (Product code 2B1309, NDC 0338-0049-38), Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.	Lot #: a) P297283, Exp 08/14; b) P292326, Exp 04/14; P293993, Exp 05/14; and P293514, Exp 04/14	Class I	Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution.	Baxter Healthcare Corp.
Drugs	Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1000 mLCLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1115-04.	Lot#: P287045, Exp 6/2014	Class I	Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.	Baxter Healthcare Corp.
Drugs	Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-1115-04.	Lot#: P275883, Exp 10/2013	Class I	Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.	Baxter Healthcare Corp.
Drugs	Clinimix 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1099-04.	Lot# P285122, Exp 5/2014	Class I	Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.	Baxter Healthcare Corp.
Food	Good Neighbors Specialty Foods Tabouli Salad; 8 oz plastic container; UPC 18561500007 and 14 oz plastic container; 18561500068	B339	Class II	Customer found blade inside the salad.	Good Neighbors Specialty Foods, LLC
Biologics	Red Blood Cells Leukocytes Reduced	W042013052033C	Class III	Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.	Blood Systems, Inc. DBA United Blood Services
Devices	ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin formed from ceramised bone for implantation or transplantation when bone is lost due to trauma or requested during reconstructive surgery.	Model # ROX05, Batch # S0171051	Class III	Individual pieces of a batch of Biomet's Endobon Xenograft Granules 0.5 ML (Bovine Bone substitute) may have an incorrect label with the wrong batch number.	Biomet 3i, LLC
Devices	VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part Number J02315; Made in USA by Ortho- Clinical Diagnostics, Inc. 100 Indigo Creek Drive, Rochester, NY 14626 --- This product is a part/ tool used when performing the correction factors adjustment on the VITROS Chemistry Systems. It does not have a 510(k) number. Because the WCF slide is a part/ tool, and is not a device used for diagnostic testing, there is no Intended Use statement. The following summary is provided as a description/ explanation of the WCF slide. The WCF slide is a part/ tool used in the reflectometer correction factor adjustment procedure in order to optimize the optical calibration of the VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600 Integrated	Lot 9052-0045-6358, expiry date 01 Aug 2015	Class II	An incorrect assay value (0.3785) was printed on the product carton for the 460 nm wavelength (filter) that may cause a delay in the ability to obtain and report TBIL, Bu, Bc, and derived tests results. The correct assay value is 0.8658.	Ortho-Clinical Diagnostics
Biologics	Red Blood Cells Leukocytes Reduced	W053513021187	Class III	Blood product, which did not meet acceptable product specifications, was distributed.	Central Jersey Blood Center, Inc.
Biologics	Red Blood Cells	W036811129421	Class II	Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.	OneBlood, Inc.
Biologics	Blood and Blood Products for Reprocessing	W036811129421	Class III	Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.	OneBlood, Inc.
Biologics	Platelets Pooled Leukocytes Reduced	W036813807738	Class II	Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.	OneBlood, Inc.
Biologics	Fresh Frozen Plasma	W036813120047	Class II	Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed	OneBlood, Inc.
Biologics	Red Blood Cells Leukocytes Reduced	W036813120047	Class II	Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed	OneBlood, Inc.
Biologics	Cryoprecipitated AHF, Pooled	W333613056988	Class II	Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.	Mississippi Valley Reg Bld Ctr
Biologics	Blood and Blood Products for Reprocessing	W333613055388; W333612069481	Class II	Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.	Mississippi Valley Reg Bld Ctr
Biologics	Source Plasma	0700212145	Class II	Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.	Biomat USA, Inc
Biologics	Red Blood Cells Leukocytes Reduced	W036813160797	Class II	Blood product, mislabeled as to antigen phenotype, was distributed.	OneBlood, Inc.
Biologics	Blood and Blood Products for Reprocessing	002K50984	Class III	Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.	American Red Cross Blood Services
Biologics	Red Blood Cells	2522469	Class II	Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.	OneBlood, Inc.
Biologics	Cryoprecipitated AHF	2522469	Class II	Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.	OneBlood, Inc.
Biologics	Red Blood Cells Leukocytes Reduced	W702113004590	Class II	Blood product, which did not meet the acceptable product specifications, was distributed.	Southern California Permanente Medical Group
Biologics	Blood and Blood Products for Reprocessing	02K50984	Class III	Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.	American Red Cross Blood Services
Biologics	Platelets Pooled Leukocytes Reduced	W044114003315	Class II	Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.	LifeServe Blood Center
Biologics	Red Blood Cells	W038113338931	Class II	Blood products, routine testing/testing performed, interpreted, or documented incorrectly, was distributed.	OneBlood, Inc.
Biologics	Cryoprecipitated AHF, Pooled	W038113986219; W038113986203; W038113986180; W038113986151; W038113986204	Class III	Blood products, not manufactured in accordance to current Good Manufacturing Practices, were distributed.	OneBlood, Inc.
Devices	Buzzaround XL scooters' Product Usage: mobility	GB 116 and GB146 series, with multiple serial numbers	Class II	Buzzaround XL scooters' front to rear lockup can become unintentionally disengaged due to possible improper fit of the front alignment cup to the rear alignment screw.	Golden Technologies, Inc.
Biologics	Platelets Pheresis Leukocytes Reduced	W158013703093; W158013703093; W158013703093; W158013703098; W158013703105; W158013703105; W158013703109; W158013703109; W158013703115; W158013703115; W158013703119; W158013703119; W158013703124; W158013703131; W158013703139; W158013703139; W158013703144; W158013703144; W158013703148; W158013703153; W158013703155; W158013703155; W158013703159; W158013703164; W158013703168; W158013703168; W158013703168; W158013703170; W158013703175; W158013703179; W158013703179; W158013703188; W158013703189; W158013703189; W158013703194; W158013703195	Class II	Blood products, which did not meet the acceptable product specifications, were distributed.	Arup Laboratories, Inc.
Drugs	Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution, in 3 ml single dose syringes; a multi-ingredient compounded medication in bulk, containing Benzoyl Benzoate USP 0.46 ml/1ml, and Benzyl Alcohol 0.02 ml/1ml; syringe is labeled in part ***FOR INJECTION USE ONLY***RX South LLC DBA RX3 12230 Iron Bridge Rd Chester, VA 23831***	Lot number: 12052013:03 Expiration date: 06/03/2014	Class II	Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping	RX South LLC DBA RX3 Pharmacy
Food	Item number T3695, White cheddar jalapeno seasoning powder, 50 lb bags.	Lots 34577 and 40257	Class I	All American Seasonings is recalling T3695 White cheddar jalapeno seasoning powder, lots 34577 and 40257 after being notified by Elite spice that there was a potential recall for salmonella in the Jalapeno powder they received.	All American Seasonings
Devices	FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. Store at room temperature below 86 degrees F (30 degrees C). Use test strips only within the system operating temperature range as outlined in your Owner's Booklet. Meter made in China; Distributed by Abbott Diabetes Care, Alameda, CA The FreeStyle mete should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions with the FreeStyle Mete can product inaccurate results. The FreeStyle Glucose meter is incorporated into the OmniPod insulin Management system (manufactured by Insulet Corporation, Bedford, MA and is intended for subcutaneous delivery of insulin. Intended to monitor blood glucose from samples taken from the body. IVD use only,	Part number CAT11001-0; all serial numbers	Class I	Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control solution results and/or erroneously low blood glucose results when used in conjunction with Free Style test strips lots within expiry.	Abbott Diabetes Care, Inc.
Devices	FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Distributed by TheraSense, Alameda, CA The FreeStyle Flash meter should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions with the FreeStyle Meter can product inaccurate results. Intended to monitor blood glucose from samples taken from the body. IVD use only,	Catalog Number 17002 NDC 99073-0170-02. All serial numbers	Class I	Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control solution results and/or erroneously low blood glucose results when used in conjunction with Free Style test strips lots within expiry.	Abbott Diabetes Care, Inc.
Food	FLOUR TORTILLAS: FAJITA 6" 15 0Z UPC Code 1569602222, HOMESTYLE 8" 24 OZ UPC Code 1569602221, BURRITO 10" 28OZ UPC Code 1569602223, GRANDE 12" 36 OZ UPC Code 1569602224, JUAREZ 8" 24 OZ UPC Code 1569603337, 8" RESTAURANT 23 OZ UPC Code 1569602230, 10" RESTAURANT 28 OZ UPC Code 1569602226. Packaged in clear poly plastic bags.	Expiration Dates from December 20 to February 27, 2014	Class II	Tortillas Mexico is recalling all tortillas with the Expiration Dates from December 20 to February 27, 2014 due to metal detector malfunction during production and therefore potential for metal in product.	Tortillas Mexico Mexico, Incorporated
Food	CORN TORTILLAS: 18 CT YELLOW/WHITE 18 OZ USPC Code 1569603333, 36 COUNT YELLOW/WHITE 36 OZ USPC Code 1569603335/4, 75 COUNT WHITE CORN 5 LB,USPC Code 1569603331, 100 COUNT WHITE CORN 100 OZ USPC Code 1569603336, 36 COUNT MINI 24 OZ USPC Code 1569603332, 36 COUNT TAQUITO 23 OZ UPC Code 1569603345, 100 COUNT TAQUITO 4 LB UPC Code 1569603346. Packaged in clear poly plastic bags.	Expiration Dates from December 20 to February 27, 2014	Class II	Tortillas Mexico is recalling all tortillas with the Expiration Dates from December 20 to February 27, 2014 because a meatal staple was found by a consumer in a baked tortilla. Investigation by the Colorado Health Department found the firm's metal detector was not functioning.	Tortillas Mexico Mexico, Incorporated
Food	WHEAT TORTILLAS: 9 COUNT, 18 OZ, UPC Code 1569602225. Packaged in clear poly plastic bags.	Expiration Dates from December 20 to February 27, 2014	Class II	Tortillas Mexico is recalling all tortillas with the Expiration Dates from December 20 to February 27, 2014 because a meatal staple was found by a consumer in a baked tortilla. Investigation by the Colorado Health Department found the firm's metal detector was not functioning.	Tortillas Mexico Mexico, Incorporated
Devices	Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C3-T3) spine.	size 3.5mm x 10mm, Catalog #05-000-20-3510, Lot Number #35917001. size 3.5mm x 14mm, Catalog #05-000-20-3514, Lot Number 35917002 and 40023002. size 3.5mm x 20mm, Catalog #05-000-20-3520, Lot Number 35917003. size 3.5mm x 26mm, Catalog #05-000-20-3526, Lot Number 35917004. size 4.0mm x 14mm, Catalog #05-000-20-4014, Lot Number 35917005. size 4.0mm x 20mm, Catalog #05-000-20-4020, Lot Number 35917006. size 4.0mm x 26mm, Catalog #05-000-20-4026, Lot Number 35917007. 1/4 Shank, size 3.5mm x 26mm, Catalog #05-000-20-3526, Lot Number 35917008. 1/4 Shank, size 3.5mm x 30mm, Catalog #05-000-20-3530, Lot Number 35917009. 1/4 Shank, size 4.0mm x 26mm, Catalog #05-000-20-4026, Lot Number 35917010. 1/4 Shank, size 4.0mm x 30mm, Catalog #05-000-20-4030, Lot Number 35917011.	Class II	The products have been identified to contain springs which have been manufactured with type-304 stainless steel rather than the specified titanium alloy.	Exactech, Inc.
Devices	Gender Solutions" Natural-Knee® Flex System: N-K FLEX MBACK SZ 0 PAT N-K FLEX MBACK SZ 1 PAT N-K FLEX MBACK SZ 2 PAT	Item Numbers 00541800000 00541800001 00541800002	Class II	A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.	Zimmer, Inc.
Devices	Natural-Knee® N-K II DOMED ALL-POLY PAT, SZ0 N-K II DOMED ALL-POLY PAT, SZ1	Item Number 00591101128 00591101137	Class II	A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.	Zimmer, Inc.
Devices	MOST Options" System (MOST) HINGED TIB INS SZ 1 16MM HINGED TIB INS SZ 4 6MM M HINGED TIB INS SZ 4 9MM M HINGED TIB INS SZ 4 16MM MOST PROX TIB INS 6MM	Item Number 502001016 502004006 502004009 502004016 502010006	Class II	A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.	Zimmer, Inc.
Devices	Natural-Knee® II - Unicompartmental Knee Prosthesis: CONG TIB INS SZ1/2 9MM UN CONG TIB INS SZ1/2 11MM U CONG TIB INS SZ1/2 13MM U CONG TIB INS SZ3/4 9MM UN CONG TIB INS SZ3/4 11MM U CONG TIB INS SZ3/4 13MM U CONG TIB INS SZ 5/6 9MM U CONG TIB INS SZ5/6 11MM U CONG TIB INS SZ5/6 13MM U	Item Number 611001009 611001011 611001013 611002009 611002011 611002013 611003009 611003011 611003013	Class II	A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.	Zimmer, Inc.
Devices	Natural-Knee® II Unicompartmental Knee System: UNI ALL-POLY TIB SZ 1-7mm UNI ALL-POLY TIB SZ 1-9mm	Item Number 613001007 613001009	Class II	A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.	Zimmer, Inc.
Devices	Natural-Knee®/Apollo" Knee: M/B PAT SZ0 NATURAL-KNEE M/B PAT SZ1 NATURAL-KNEE M/B PAT SZ2 NATURAL-KNEE	Item Number 620001100 620001101 620001102	Class II	A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.	Zimmer, Inc.
Devices	Natural-Knee® Congruent Tibial Insert with Screw: SF-CON TIB INS LT SZ1/2 1 SF-CON TIB INS RT SZ1/2 9 SF-CON TIB INS RT SZ3/4/5	Item Number 620005819 620005909 620006916	Class II	A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.	Zimmer, Inc.
Devices	Natural-Knee® II System ULTRA CONG INS LT SZA/9MM ULTRA CONG INS LT SZA/13M ULTRA CONG INS LT SZA/19M ULTRA CONG INS RT SZA/9MM ULTRA CONG INS RT SZA/11M ULTRA CONG INS RT SZA/13M ULTRA CONG INS RT SZA/19M ULTRA CONG INS LT SZB/13M ULTRA CONG INS LT SZB/16M ULTRA CONG INS RT SZB/19M ULTRA CONG INS RT SZB/22M NKII ROT PLTFM U/C INS, 9 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 ALL POLY CONG TIB LT SZ00 ALL POLY CONG TIB LT SZ0/ ALL POLY CONG TIB LT SZ0/ ALL POLY CONG TIB RT SZ0/ ALL POLY CONG TIB RT SZ0/ ALL POLY CONG TIB LT SZ1/ ALL POLY CONG TIB LT SZ1/ ALL POLY CONG TIB RT SZ1/ ALL POLY CONG TIB RT SZ1/ ALL POLY CONG TIB RT SZ1/ ALL POLY CONG TIB LT SZ2/ ALL POLY CONG TIB LT SZ2/ ALL POLY CONG TIB LT SZ2/ ALL POLY CONG TIB LT SZ2/ ALL POLY CONG TIB RT SZ2/ ALL POLY CONG TIB RT SZ2/ ALL POLY CONG TIB RT SZ2/ ALL POLY CONG TIB LT SZ3/ ALL POLY CONG TIB LT SZ3/ ALL POLY CONG TIB LT SZ3/ ALL POLY CONG TIB RT SZ3/ ALL POLY CONG TIB RT SZ3/ ALL POLY CONG TIB RT SZ3/ ALL POLY CONG TIB LT SZ4/ ALL POLY CONG TIB LT SZ4/ ALL POLY CONG TIB RT SZ4/ ALL POLY CONG TIB RT SZ4/ ALL POLY CONG TIB RT SZ5/ PS TIB INS RT SZ1/2 16MM PS TIB INS RT SZ1/2 19MM PS TIB INS LT SZ00/0 19MM PS TIB INS RT SZ00/0 11MM PS TIB INS RT SZ00/0 16MM	Item Number 625001609 625001613 625001619 625001709 625001711 625001713 625001719 625002613 625002616 625002719 625002722 630809510 630811410 630811510 630813410 630813510 630816210 630816410 630816510 630819010 630819110 630819210 630819310 630819410 630819510 635000009 635001009 635001011 635001111 635001116 635002009 635002011 635002109 635002111 635002113 635003009 635003011 635003013 635003016 635003109 635003113 635003116 635004009 635004011 635004016 635004111 635004113 635004119 635005013 635005019 635005111 635005116 635006109 670501916 670501919 670503819 670503911 670503916	Class II	A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.	Zimmer, Inc.
Devices	Natural-Knee® II Constrained Knee System NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ1/2-RT NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ1/2-RT NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ1/2-RT NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ00/0-R	Item Number 672009100 672009101 672009103 672009200 672009203 672011101 672011103 672011200 672011201 672011203 672013100 672013101 672013103 672013200 672013203 672016101 672016103 672016200 672016203 672019100 672019101 672019200 672019201 672022101 672022103 672022200 672022201 672025100 672025200	Class II	A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.	Zimmer, Inc.
Devices	Natural-Knee® II Posterior Stabilized (P.S.) Condylar Tibial Inserts: N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS INS TIB SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ	Item Number 672509100 672509101 672509200 672509203 672511100 672511103 672513101 672513103 672513201 672516103 672519103 672522201 672525103 672525203	Class II	A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.	Zimmer, Inc.
Devices	Apollo" Knee System: APOLLO PATELLA SZ0 28MM R	Item Number 680001000	Class II	A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.	Zimmer, Inc.
Devices	Apollo Knee Tibial Baseplate/Knee Tibial Insert: CONG TIB INS SZ0/19MM APO CONG TIB INS SZ0/22MM APO CONG TIB INS SZ1/9MM APOL CONG TIB INS SZ1/11MM APO CONG TIB INS SZ1/19MM APO CONG TIB INS SZ2/13MM APO CONG TIB INS SZ2/19MM APO CONG TIB INS SZ3/9MM APOL CONG TIB INS SZ3/13MM APO	Item Number 681100019 681100022 681101009 681101011 681101019 681102013 681102019 681103009 681103013	Class II	A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.	Zimmer, Inc.
Devices	Apollo" Knee System: PS TIB INS SZ0/16MM APOLL PS TIB INS SZ0/19MM APOLL PS TIB INS SZ0/22MM APOLL PS TIB INS SZ1/16MM APOLL PS TIB INS SZ2/16M APOLLO PS TIB INS SZ2/22MM APOLL PS TIB INS SZ3/16MM APOLL PS TIB INS SZ3/19MM APOLL PS TIB INS SZ4/9MM APOLLO PS TIB INS SZ4/11MM APOLL PS TIB INS SZ4/13MM APOLL PS TIB INS SZ4/16MM APOLL PS TIB INS SZ4/19MM APOLL PS TIB INS SZ4/22MM APOLL PS TIB INS SZ5/9MM APOLLO PS TIB INS SZ5/19MM APOLL	Item Number Item Number 681600016 681600019 681600022 681601016 681602016 681602022 681603016 681603019 681604009 681604011 681604013 681604016 681604019 681604022 681605009 681605019	Class II	A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.	Zimmer, Inc.
Devices	Apollo" Revision/Constrained Knee System: SZ0-16MM AK CCK TIB INSER SZ1-11MM AK CCK TIB INSER SZ1-16MM AK CCK TIB INSER SZ1-22MM AK CCK TIB INSER SZ1-30MM AK CCK TIB INSER SZ2-11MM AK CCK TIB INSER SZ2-13MM AK CCK TIB INSER SZ2-16MM AK CCK TIB INSER SZ2-22MM AK CCK TIB INSER SZ2-30MM AK CCK TIB INSER SZ3-16MM AK CCK TIB INSER SZ3-22MM AK CCK TIB INSER SZ3-25MM AK CCK TIB INSER SZ4-13MM AK CCK TIB INSER SZ4-16MM AK CCK TIB INSER SZ5-11MM AK CCK TIB INSER	Item Number 682000016 682001011 682001016 682001022 682001030 682002011 682002013 682002016 682002022 682002030 682003016 682003022 682003025 682004013 682004016 682005011	Class II	A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.	Zimmer, Inc.
Devices	Natural-Knee® II System: POLY ULTRA TIB LT SZ00/9M POLY ULTRA TIB LT SZ0/9MM POLY ULTRA TIB LT SZ0/19M POLY ULTRA TIB RT SZ0/13M POLY ULTRA TIB RT SZ0/16M ALL POLY ULTRA TIB LT SZ1 ALL POLY ULTRA TIB RT SZ1 ALL POLY ULTRA TIB LT SZ2 ALL POLY ULTRA TIB LT SZ2 ALL POLY ULTRA TIB RT SZ2 ALL POLY ULTRA TIB LT SZ3 ALL POLY ULTRA TIB RT SZ3 ALL POLY ULTRA TIB RT SZ5	Item Number 621800809 621801809 621801819 621801913 621801916 621810816 621810909 621820809 621820811 621820911 621830811 621830909 621850916	Class II	A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.	Zimmer, Inc.
Devices	Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment..	Serial Numbers: 1294627, 1298383, 1298386, 1299352, 1299353, 1299354, 1299355, 1299356, 1299486, 1299487, 1299488, 1299489, 1299503, 1299572, 1299712, 1299713, 1299716, 1299718, 1299719, 1299720, 1299740, 1299742, 1299777, 1299779, 1299780, 1299831, 1299835, 1299850, 1299867, 1299868, 1299895, 1299897, 1299992, 1299993, 1299994, 1299996, 1299997, 1300138, 1300224, 1300248, 1300363, 1300364, 1300367, 1300368, 1300558, 1300560, 1300561, 1300562, 1300564, 1300565, 1300621, 1300649, 1300650, 1300700, 1300701, 1301081, 1301116, 1301360, 1301361, 1301386, 1301888, 1301990, 1301992, 1301997, 1302030, 1302032, 1302149, 1302214, 1302226, 1302342, 1302345, 1302346, 1302385, 1302430, 1302447, 1302448, 1302452, 1302456, 1302464, 1302517, 1302555, 1302558, 1302642, 1302696, 1302706, 1302708, 1302748, 1302767, 1302768, 1302810, 1302813, 1302922, 1302923, 1302924, 1302925, 1302926, 1302927, 1302987, 1303005, 1303108, 1303315, 1303316, 1303346, 1303348, 1303351, 1303352, 1303505, 1303516, 1303532, 1303533, 1303534, 1303557, 1303558, 1303625, 1303626, 1303689, 1303690, 1303693, 1303702, 1303711, 1303768, 1303781, 1303799, 1303806, 1303821, 1303872, 1303877, 1303908, 1303920, 1303975, 1303976, 1304070, 1304076, 1304077, 1304081, 1304163, 1304166, 1304167, 1304170, 1304173, 1304174, 1304194, 1304196, 1304203, 1304273, 1304293, 1304294, 1304297, 1304333, 1304340, 1304343, 1304344, 1304346, 1304349, 1304376, 1304381, 1304501, 1304502, 1304503, 1304507, 1304508, 1304551, 1304585, 1304587, 1304724, 1304725, 1304775, 1304778, 1304779, 1304829, 1304870, 1304902, 1304903, 1304929, 1305006, 1305007, 1305038, 1305040, 1305041, 1305087, 1305088, 1305089, 1305131, 1305133, 1305210, 1305238, 1305239, 1305355, 1305363, 1305608, 1305609, 1305650, 1305651, 1305655, 1305698, 1305700, 1305701, 1305717, 1305732, 1305735, 1305750, 1305751, 1305752, 1305795, 1305928, 1305931, 1305932, 1305975, 1305995, 1306007, 1306042, 1306046, 1306078, 1306125, 1306154, 1306178, 1306209, 1306215, 1306226, 1306259, 1306322, 1306341, 1306428, 1306429, 1306430, 1306431, 1306432, 1306654, 1306662, 1306663, 1306664, 1306665.	Class II	High inlet water pressure beyond specification and the solenoid valve does not meet application which could result in a delay in treatment.	Mar Cor Purification
Devices	Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered. Surgical powered Laser instruments.	Denlase and Penlase Dental Laser Systems.	Class II	Failure to provide calibration procedures to purchasers, as required by 21 CFR 1040.11(a)(2). For example, the user manual did not contain calibration procedures for Denlase or Penlase Lasers	China Daheng Group Inc.
Devices	Product Brand Name(s): Alere Triage® TOX+MTD Drug Screen, Catalog Number 94400, Lots W56013B and W56035B. 25 individually pouched devices in a labeled kit box. Indications for use: The Alere Triage® TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Triage® Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses. This test provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography/ Mass Spectrometry/ Mass Spectrometry (LC/MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods. A quantitative serum acetaminophen/paracetamol measurement is the common confirmatory method for preliminary positive acetaminophen/paracetamol results.	Catalog Number 94400, Lots W56013B and W56035B	Class II	Alere San Diego, Inc. is initiating a recall of the Alere Triage® TOX Drug Screen, Catalog Number 94400, Lots W56013B and W56035B because Alere's investigation has shown that these lots have a frequency of false negative results for PCP (Phencyclidine) that is higher than the frequency shown in the package insert. If you have questions about previously reported results.	Alere San Diego, Inc.
Biologics	Source Plasma	TT0306091; TT0307155; TT0307638; TT0305128; TT0305458	Class II	Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.	DCI Biologicals Temple Terrace, LLC
Biologics	Source Plasma	TT0332120; TT0332466; TT0332926; TT0298638; TT0299019; TT0299579; TT0300059; TT0302035; TT0302785; TT0303087; TT0303804; TT0310875; TT0311187; TT0319719; TT0320023; TT0320584; TT0321162; TT0321623; TT0322549; TT0322679; TT0323400; TT0323655; TT0324230; TT0324464; TT0325344; TT0325718; TT0326545; TT0326954; TT0327595; TT0327837; TT0328375; TT0328664; TT0329243; TT0329742; TT0330045; TT0330481; TT0330841; TT0331263; TT0331645	Class II	Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.	DCI Biologicals Temple Terrace, LLC
Biologics	Source Plasma	BY0386092; BY0386376; BY0387157; BY0387287; BY0387767; BY0387954; BY0388378	Class III	Blood products, collected from a donor who was previously deferred, were distributed.	DCI Biologicals, LLC
Biologics	Source Plasma	TT0297450; TT0297848; TT0298354; TT0298821	Class II	Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.	DCI Biologicals Temple Terrace, LLC
Devices	syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673	Model nos.10091804, 10091805, 10091806, 10091807, 10091673. syngo Dynamics Version 9.5 using Sensis integration.	Class II	Potential patient data mixup. Improper error handling could allow for two different patients to be displayed in syngo Dynamics. Images shown for one patient and reporting system shown for a different patient, leading to the potential for misdiagnosis.	Siemens Medical Solutions USA, Inc
Devices	Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069. The Reusable Clip Applier (Applier) is intended to be used to deploy the Gillinov-Cosgrove LAA Clip (Clip). The Gillinov-Cosgrove LAA Clip (Clip) is an implantable device used for occlusion of the left atrial appendage.	Lot Number MFR-0424-1	Class II	The firm was notified by a customer of a cracked spring in the handle of the RCD1 device.	Atricure Inc
Food	Creation Special Snack Mix; 25 lb. cardboard carton	Lot #s: 13037, 13114, 13309 and 13333.	Class II	Due to the lack of the ingredient statement the firm failed to declare the following direct allergens: peanuts, tree nuts, soy, wheat, and yellow #5. The products also lack the declaration that they are packaged in a facility that handles milk and eggs.	Dayton Nut Specialties Inc
Food	Bar Star Snack Mix; 25 lb. cardboard carton	Lot #s: 13013037, 13078, 13114, 13163, 13227, 13288 and 13333.	Class II	Due to the lack of the ingredient statement the firm failed to declare the following direct allergens: peanuts, tree nuts, soy, wheat, and yellow #5. The products also lack the declaration that they are packaged in a facility that handles milk and eggs.	Dayton Nut Specialties Inc
Devices	MEDITECH Microbiology; Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14. Integrates requisition, specimen processing, and patient information with data in the healthcare information system (HCIS).	Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14.	Class II	Potential for erroneous result reporting.	Medical Information Technology, Inc.
Biologics	Source Plasma	3520277021; 3520276367; 3520275784; 3520275235; 3520274652; 3520273706; 3520272384; 3520272017; 3520271116; 3520270771; 3520268608; 3520268234; 3520267426; 3520266968	Class III	Blood products, collected from a donor who was previously deferred, were distributed.	Talecris Plasma Resources, Inc
Food	4 oz. Heart - Shaped Box of Assorted Chocolates	13344, 13345, 13361, 14010, 14014, 12365, and 13002.	Class I	Undeclared Allergen - peanut	Fannie May Confection Brands Inc
Devices	Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces model number DNYD11914 Product Usage:Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.	540204R001	Class II	The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.	Convatec Inc.
Devices	Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated (Latex) 5- 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.	540204R001	Class II	The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.	Convatec Inc.
Devices	SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.	540204R001	Class II	The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.	Convatec Inc.
Devices	JMS, Japan, 3 WAY, 20 FR 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.	540204R001	Class II	The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.	Convatec Inc.
Devices	'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.	540204R001	Class II	The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.	Convatec Inc.
Devices	SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.	540204R001	Class II	The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.	Convatec Inc.
Devices	Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.	Lot 1174497, exp. 2015/04	Class II	Some of the discs may not be impregnated with the antibiotic.	Remel Inc
Devices	GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 series of Computed Tomography systems are intended to produce cross-sectional images of the body by computer reconstruction of XRay transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), and Gated (Respiratory and Cardiac) acquisitions in patients of all ages.	Mfg Lot or Serial # PA2314840 PA2314841 PA2314842 PA2314843 PA2314844 PA2314845 A1RF3176G A1RF3638GR A2RF1052G B1RF4038GR B3G44377G B3G44511G B3G44515G B3RF4960G C1RF4686G C1RF4793G C1RF4802G C1RF4827GR D2RF2744G D2RF2778GR D2RF2795G D2RF2796G D2RF2797G D2RF2798G D2RF2799G D2RF2814G D2RF2815G D2RF2816G D2RF2817G D2RF2818G D2RF2819G D2RF2820G D2RF2821G D2RF2822G D2RF2823G D2RF2824G D2RF2825G D2RF2826G D2RF2827G D2RF2828G D2RF2829G D2RF2830G D2RF2831G D2RF2832G D2RF2833G D2RF2834G D2RF2835G D2RF2836G D2RF2837G D2RF2838G D2RF2839G D2RF2840G D2RF2841G D2RF2842G D2RF2843G D2RF2844G D2RF2845G D2RF2846G D2RF2847G D2RF2848G D2RF2850G D2RF2851G D3G44977G D3G44983G D3G44984G D3G44985G D43T4071G D43T4072G D43T4073G D43T4074G D43T4075G D43T4076G D43T4077G E1RF5364G E1RF5479GR E1RF5480GR E1RF5599G E3RF5317G E3RF5318G F0RF0134G F0RF0135G F0RF0136G F0RF0140G F0RF0141G F1RF4827GR F1RF5952G F1RF6042GR F1RF6075GR F1RF6079GR F1RF6084GR F1RF6085GR F1RF6086GR F1RF6088GR F1RF6092GR F1RF6097GR F1RF6100GR 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SJ812170209GA SJ812170210GA SJ812170211GA SJ812170212GA SJ812170213GA SJ812170214GA SJ812170215GA SJ812170216GA SJ812170217GA SJ812180218GA SJ812180219GA SJ812180220GA SJ812180221GA SJ812180222GA SJ812180223GA SJ812180224GA SJ812180225GA SJ812180227GA SJ812180228GA SJ812180229GA SJ812180230GA SJ812180231GA SJ812180232GA SJ812180233GA SJ812180234GA SJ812180235GA SJ812180236GA SJ812180237GA SJ812180238GA SJ812180240GA SJ812180241GA SJ812180242GA SJ812180243GA SJ812180244GA SJ812180245GA SJ812180246GA SJ812180247GA SJ812180248GA SJ812180249GA SJ812180252GA SJ812180253GA SJ812180254GA SJ812180255GA SJ812180256GA SJ812180258GA SJ812180259GA SJ812180260GA SJ812180261GA SJ812180262GA SJ812180263GA SJ812180264GA SJ812180265GA SJ812180266GA SJ812180267GA SJ812180268GA SJ812180269GA SJ812180270GA SJ812180272GA SJ812180275GA SJ812180277GA SJ812180278GA SJ812180279GA SJ812180282GA SJ812180283GA SJ812180284GA SJ812180285GA SJ812180286GA SJ812180287GA SJ812180288GA SJ812190289GA SJ812190290GA 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SJ812290386GA SJ812290387GA SJ812290388GA SJ812290389GA SJ812290390GA SJ812290391GA SJ812290392GA SJ812290393GA SJ812290394GA SJ812300396GA SJ812300397GA SJ812300398GA SJ812300399GA SJ812300400GA SJ812300401GA SJ812300402GA SJ812300404GA SJ812300405GA SJ812300406GA SJ812300407GA SJ812300408GA SJ812300409GA SJ812300411GA SJ812300412GA SJ812300413GA SJ812300414GA SJ812300416GA SJ812300417GA SJ812300418GA SJ812300419GA SJ812300420GA SJ812300421GA SJ812300422GA SJ812300423GA SJ812300424GA SJ812300425GA SJ812310426GA SJ812310427GA SJ812310428GA SJ812310429GA SJ812310430GA SJ812310431GA SJ812310432GA SJ812310433GA SJ812310434GA SJ812310435GA SJ812310436GA SJ812310438GA SJ812310439GA SJ812310440GA SJ812310441GA SJ812310442GA SJ812310443GA SJ812310444GA SJ812310445GA SJ812310446GA SJ812310447GA SJ812310448GA SJ812310449GA SJ812310450GA SJ812310451GA SJ812310452GA SJ812310453GA SJ812310454GA SJ812310455GA SJ812310456GA SJ812310457GA SJ812310458GA SJ812310460GA SJ812310461GA SJ812310463GA SJ812310464GA SJ812310465GA SJ812310466GA SJ812310467GA SJ812310468GA SJ812310470GA SJ812310471GA SJ812310472GA SJ812310473GA SJ812310475GA SJ812310478GA SJ812310481GA SJ812310494GA SJ812310497GA SJ812310501GA SJ812310504GA SJ812320506GA SJ812320507GA SJ812320508GA SJ812320509GA SJ812320510GA SJ812320515GA SJ812320516GA SJ812320517GA SJ812320518GA SJ812320520GA SJ812320523GA SJ812320526GA SJ812320528GA SJ812320529GA SJ812370664GA SJ812370668GA SJ812370669GA SJ812370670GA SJ812370671GA SJ812370672GA SJ812370673GA SJ812380684GA SJ812380685GA SJ812380686GA SJ812380687GA SJ812380688GA SJ812380689GA SJ812380690GA SJ812380691GA SJ812380692GA SJ812380693GA SJ812400752GA SJ812400753GA SJ812410791GA SJ812410792GA SJ812410793GA SJ812410794GA SJ812410795GA SJ812410796GA SJ812410799GA SJ812410804GA SJ812410805GA SJ812410807GA SJ812410815GA SJ812410829GA SJ812410832GA SJ812410833GA SJ812410835GA SJ812410836GA SJ812410837GA SJ812410838GA SJ812410839GA SJ812410840GA SJ812410841GA SJ812410843GA SJ812410850GA SJ812410854GA SJ812410855GA SJ812410856GA SJ812410857GA SJ812410859GA SJ812410860GA SJ812410861GA SJ812410863GA SJ812410866GA SJ812410867GA SJ812410874GA SJ812410875GA SJ812410879GA SJ812420880GA SJ812420881GA SJ812420883GA SJ812420886GA SJ812420887GA SJ812420888GA SJ812420891GA SJ812420908GA SJ812420910GA SJ812420911GA SJ812420912GA SJ812420913GA SJ812420914GA SJ812420917GA SJ812420918GA SJ812420919GA SJ812420920GA SJ812420921GA SJ812420922GA SJ812420923GA SJ812420924GA SJ812420925GA SJ812420926GA SJ812420927GA SJ812420928GA SJ812420929GA SJ812420930GA SJ812420931GA SJ812420932GA SJ812420933GA SJ812420934GA SJ812420935GA SJ812420937GA SJ812420944GA SJ812431060GA SJ812431061GA SJ812431062GA SJ812431063GA SJ812431064GA SJ812431065GA SJ812431066GA SJ812431068GA SJ812431069GA SJ812431070GA SJ812431071GA SJ812431072GA SJ812431074GA SJ812431075GA SJ812431076GA SJ812431077GA SJ812431078GA SJ812431079GA SJ812431081GA SJ812431082GA SJ812431084GA SJ812431086GA SJ812431087GA SJ812431088GA SJ812431089GA SJ812431091GA SJ812431092GA SJ812431094GA SJ812431095GA SJ812431096GA SJ812431098GA SJ812431099GA SJ812431105GA SJ812431106GA SJ812431107GA SJ812431109GA SJ812431110GA SJ812431111GA SJ812431112GA SJ812431113GA SJ812431114GA SJ812431115GA SJ812431116GA SJ812431117GA SJ812431118GA SJ812431119GA SJ812431120GA SJ812431121GA SJ812431122GA SJ812431123GA SJ812431124GA SJ812431125GA SJ812431126GA SJ812431127GA SJ812431128GA SJ812431129GA SJ812431130GA SJ812431131GA SJ812431135GA SJ812431136GA SJ812431137GA SJ812431138GA SJ812431139GA SJ812431140GA SJ812441141GA SJ812441143GA SJ812441144GA SJ812441145GA SJ812441146GA SJ812441147GA SJ812441148GA SJ812441149GA SJ812441151GA SJ812441153GA SJ812441154GA SJ812441155GA SJ812441156GA SJ812441157GA SJ812441158GA SJ812521228GA SJ812521229GA SJ812521230GA SJ812521231GA SJ812521232GA SJ812521233GA SJ812521234GA SJ812521235GA SJ812521236GA SJ812521238GA SJ813001244GA SJ813001245GA SJ813001246GA SJ813001247GA SJ813001248GA SJ813051259GA SJ813051260GA SJ813051261GA SJ813051262GA SJ813051263GA SJ813051270GA SJ813051272GA SJ813051273GA SJ813051274GA SJ813051275GA SJ813051277GA SJ813051278GA SJ813051280GA SJ813051281GA SJ813051282GA SJ813051283GA SJ813051286GA SJ813061290GA SJ813061292GA SJ813061293GA SJ813061294GA SJ813081334GA SJ813081336GA SJ813081337GA SJ813081338GA SJ813081339GA SJ813081340GA SJ813081341GA SJ813081342GA SJ813081343GA SJ813081344GA SJ813081345GA SJ813081346GA SJ813091355GA SJ813091356GA SJ813091358GA SJ813091359GA SJ813091360GA SJ813091361GA SJ813091365GA SJ813091368GA SJ813091371GA SJ813091374GA SJ813091375GA SJ813091376GA SJ813091378GA SJ813091379GA SJ813091380GA SJ813091391GA SJ813091392GA SJ813091393GA SJ813091394GA SJ813091395GA SJ813091396GA SJ813091397GA SJ813091398GA SJ813091399GA SJ813091400GA SJ813091405GA SJ813091406GA SJ813091407GA SJ813101411GA SJ813101412GA SJ813101423GA SJ813101424GA SJ813101427GA SJ813101428GA SJ813101429GA SJ813101430GA SJ813101431GA SJ813101432GA SJ813101433GA SJ813101435GA SJ813101439GA SJ813101440GA SJ813101441GA SJ813101442GA SJ813111445GA SJ813111449GA SJ813111452GA SJ813131454GA SJ813131455GA SJ813131456GA SJ813131457GA SJ813131458GA SJ813131459GA SJ813131460GA SJ813131461GA SJ813131462GA SJ813131463GA SJ813131465GA SJ813131466GA SJ813131467GA SJ813131468GA SJ813131469GA SJ813131470GA SJ813131472GA SJ813141484GA SJ813141485GA SJ813141486GA SJ813141487GA SJ813141488GA SJ813141489GA SJ813141490GA SJ813141491GA SJ813141492GA SJ813141493GA SJ813141494GA SJ813141495GA SJ813141496GA SJ813141498GA SJ813141499GA SJ813141500GA SJ813141501GA SJ813141502GA SJ813141503GA SJ813141505GA SJ813141506GA SJ813141507GA SJ813141508GA SJ813141509GA SJ813141510GA SJ813141512GA SJ813141513GA SJ813141514GA SJ813141517GA SJ813141518GA SJ813151519GA SJ813151520GA SJ813161539GA SJ813161540GA SJ813161541GA SJ813161542GA SJ813161543GA SJ813161544GA SJ813161545GA SJ813161546GA SJ813161547GA SJ813161548GA SJ813161549GA SJ813161550GA SJ813161552GA SJ813161553GA SJ813161555GA SJ813161556GA SJ813161558GA SJ813161559GA SJ813161563GA SJ813161564GA SJ813161565GA SJ813161566GA SJ813171569GA SJ813171570GA SJ813171571GA SJ813171576GA SJ813201587GA SJ813201591GA SJ813201592GA SJ813201594GA SJ813201597GA SJ813201599GA SJ813201600GA SJ813201602GA SJ813201604GA SJ813201605GA SJ813201606GA SJ813201607GA SJ813201610GA SJ813201611GA SJ813201612GA SJ813201613GA SJ813201614GA SJ813201615GA SJ813201617GA SJ813201620GA SJ813201623GA SJ813201625GA SJ813201626GA SJ813201627GA SJ813201628GA SJ813201641GA SJ813201642GA SJ813201643GA SJ813201644GA SJ813201646GA SJ813201647GA SJ813201648GA SJ813201649GA SJ813201650GA SJ813201651GA SJ813201653GA SJ813201654GA SJ813201655GA SJ813221666GA SJ813221667GA SJ813221668GA SJ813221669GA SJ813221670GA SJ813231671GA SJ813231672GA SJ813231673GA SJ813231676GA SJ813231677GA SJ813231678GA SJ813231679GA SJ813261726GA SJ813261727GA SJ813261728GA SJ813261729GA SJ813261730GA SJ813261731GA SJ813261732GA SJ813261733GA SJ813261734GA SJ813261735GA SJ813261736GA SJ813271754GA SJ813331846GA SJ813331847GA SJ813331848GA SJ813341851GA SJ813341852GA SJ813341853GA SJ813341854GA SJ813341855GA SJ813341856GA SJ813341857GA SJ813341858GA SJ813341859GA SJ813341861GA SJ813341862GA SJ813341863GA SJ813341864GA SJ813341865GA SJ813341866GA SJ813341867GA D1RF5130G D1RF5164G M1RF9796G PA2312626 SBH05440960GA SBH05450980GA SBM06261082GA SE410125060GA SE410175359GA SE410427727GA SE410427736GA SE411120829GA SE411120834GA SE411373361GA SE411373424GA SE411373430GA SE411373450GA PA1787323 PA1990529 PA1990530 PA1990531 PA1990532 PA1990533 PA1990534 PA1990535 PA1990536 PA1990537 PA1990902 PA2007151 R3T04490894GA R3T04490895GA R3T04490902GA R3T04490904GA R3T04490905GA R3T04490906GA R3T04490907GA R3T04490908GA R3T04490909GA R3T04490910GA R3T04490911GA R3T04490912GA R3T04490937GA R3T04490941GA R3T04490942GA R3T04490945GA R3T04490946GA R3T04490947GA R3T04490948GA R3T04490949GA R3T04490952GA R3T04490953GA R3T04490954GA R3T04490955GA R3T04490956GA SE410518952GA SE410034381GA A3G44075G SE410296397GA SE410306446GA SE410306448GA SE410084705GA SE410084821GA SE411171508GA SE411171514GA A43T2648G A43T2827G A43T2828G A43T2829G G2RF3761G G2RF3769G J2G42141G J2G42142G J2G42144G J2G42146G J2G42149G J2G42150G L33T1515G L33T1516G L33T1519G L33T1520G L33T1521G L33T1522G L33T1523G L33T1524G L33T1525G L33T1526G L33T1527G L33T1529G L33T1530G L33T1531G L33T1532G L33T1533G L33T1535G L33T1536G L33T1537G PA1786866 PA1787409 PA1787410 PA1787411 PA1787412 PA1787413 PA1787414 PA1787415 PA1787416 PA1787417 PA1787418 PA1787419 PA1787420 PA1787421 PA1787422 PA1787423 PA1787424 PA1787425 PA1787426 PA1787427 PA1787428 PA1787429 PA1787430 PA1787431 PA1787432 PA1787433 PA1853043 PA1853044 PA1853045 PA1853046 PA1853047 PA1853048 PA1853049 PA1853050 PA1853051 PA1853052 PA1853053 PA1853054 PA1853055 PA1853056 PA1853057 PA1853058 PA1853059 PA1853060 PA1853061 PA1853062 PA1853063 PA1853064 PA1853065 PA1853066 PA1853067 PA1853068 PA1853069 PA1853070 PA1853071 PA1853072 PA2138233 PA2138290 PA2139685 PA2139686 PA2139687 PA2139688 PA2139689 PA2139690 PA2139691 PA2139692 PA2139693 PA2139694 R3T04490969GA R3T04490970GA SE409452977GA SE409473201GA SE409473202GA SE409473203GA SE409473204GA SE409473205GA SE409473206GA SE409473207GA SE409473208GA SE409473215GA SE409473216GA SE409473217GA SE409473221GA SE409473237GA SE409473238GA SE409473250GA SE409473257GA SE409473258GA SE409483260GA SE409483261GA SE409483262GA SE409483263GA SE409483265GA SE409493348GA SE409493356GA SE409493361GA SE409493375GA SE409493379GA SE409493382GA SE409493385GA SE409493394GA SE409493401GA SE409493405GA SE409493406GA SE409493411GA SE409503428GA SE409503443GA SE409503446GA SE409503447GA SE409503449GA SE409503456GA SE409503458GA SE409503460GA SE409503482GA SE409503484GA SE410034386GA SE410064659GA SE410064661GA SE410064662GA SE410064663GA SE410064664GA SE410064665GA SE410064666GA SE410064667GA SE410064668GA SE410064669GA SE410074670GA SE410074671GA SE410074672GA SE410074673GA SE410074674GA SE410074675GA SE410074682GA SE410074683GA SE410074686GA SE410084749GA SE410155177GA SE410468097GA SE410468099GA SE410468105GA SE410488599GA SE410488602GA SE411191642GA SE411302542GA SE411302544GA SE411302550GA SE411302564GA SE411302573GA SE411312693GA SE411322865GA SE411322872GA SE411332985GA SE411332992GA SE411332994GA SE411332999GA SE411343032GA SE411373350GA SE411373354GA SE411373363GA SE411373365GA SE411373366GA SE411373377GA SE411373379GA SE411373380GA SE411373384GA SE411373385GA SE411373419GA SE411373423GA SE411373428GA SE411373438GA SE411383486GA SE411383497GA SE411383502GA SE411383534GA SE411383535GA SE411383537GA SE411383538GA SE411383544GA SE411383545GA SE411383550GA SE411383557GA SE411383565GA SE411393687GA SE411393693GA SE411393695GA SE411393704GA SE411393705GA SE411393709GA D1RF4986G SE411141030GA SE409432600GA SE409442784GA SE409442790GA SE409452881GA SE409452883GA SE409452884GA SE409452904GA SE409452910GA SE409452912GA SE409493387GA SE409503502GA SE409503518GA SE409503526GA SE409503528GA SE409503529GA SE409503530GA SE409503532GA SE409503533GA SE409503534GA SE409503536GA SE409503537GA SE409503538GA SE409503541GA SE409503542GA SE409503543GA SE409503551GA SE409503552GA SE409503556GA SE409503572GA SE409503574GA SE409503578GA SE409503579GA SE409503588GA SE409503590GA SE409503591GA SE409503594GA SE409503595GA SE409503596GA SE409503597GA SE409503598GA SE409503599GA SE409503600GA SE409503602GA SE409503603GA SE409503606GA SE409503610GA SE409503613GA SE409503615GA SE409503621GA SE409503622GA SE409503629GA SE409503630GA SE409503631GA SE409503632GA SE409513647GA SE409513648GA SE409513649GA SE409513652GA SE409513660GA SE409513662GA SE409513663GA SE409513664GA SE409513666GA SE409513668GA SE409513669GA SE409513672GA SE409513673GA SE409513675GA SE409513676GA SE409513677GA SE409513723GA SE409523904GA SE409523909GA SE409523913GA SE409523924GA SE409523925GA SE409523926GA SE409523927GA SE409523928GA SE409523929GA SE409523930GA SE409523931GA SE409523936GA SE409523937GA SE409523940GA SE409523943GA SE409523944GA SE409523945GA SE409523946GA SE409523954GA SE409523956GA SE409523958GA SE409523977GA SE409523979GA SE409523980GA SE409523985GA SE409523986GA SE409523991GA SE409523993GA SE409523994GA SE409523995GA SE409534041GA SE409534048GA SE409534055GA SE409534065GA SE409534084GA SE410024201GA SE410024209GA SE410024214GA SE410024241GA SE410024246GA SE410024247GA SE410024248GA SE410024249GA SE410024250GA SE410024251GA SE410024252GA SE410024253GA SE410024254GA SE410024255GA SE410024256GA SE410024257GA SE410024258GA SE410024259GA SE410024260GA SE410024261GA SE410024262GA SE410024263GA SE410024264GA SE410024265GA SE410024266GA SE410024267GA SE410024268GA SE410024269GA SE410024270GA SE410024271GA SE410024274GA SE410024275GA SE410024276GA SE410024277GA SE410024278GA SE410024279GA SE410024280GA SE410024281GA SE410024282GA SE410024283GA SE410024284GA SE410024285GA SE410024286GA SE410024287GA SE410024288GA SE410024289GA 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SE410064589GA SE410064590GA SE410064591GA SE410064592GA SE410064593GA SE410064596GA SE410064599GA SE410064600GA SE410064601GA SE410064602GA SE410064603GA SE410084830GA SE410084833GA SE410084836GA SE410084838GA SE410084839GA SE410084840GA SE410084841GA SE410094893GA SE410235629GA SE410498816GA SE410508901GA SE410508905GA SE410508914GA SE410508915GA SE410518918GA SE410518921GA SE410518922GA SE410518923GA SE410518928GA SE410518929GA SE410518930GA SE410518932GA SE410518956GA SE410518968GA SE410518982GA SE410518984GA SE410519020GA SE410519136GA SE410519139GA SE410519145GA SE411484172GA G3G46740G	Class II	GE Healthcare has recently become aware of a potential safety issue due to a software issue associated with the Head Scan Protocols used on your Optima CT580 or Discovery CT590RT scanner. A potential hazardous situation may occur during a CT head scan causing a novel and rare artifact that may hide pathology. When using the head and large head SFOV, which applies the Iterative Bone Option (IBO), the image clarity between the cranial -brain interface, may not be clinically acceptable. The artifact degrades image quality at the boundary between the cranium and brain surface, but does not affect the bone image quality. No injuries have been reported to date.	GE Healthcare, LLC
Biologics	Red Blood Cells	2262099; 2365718; 2233002	Class II	Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.	OneBlood, Inc.
Biologics	Fresh Frozen Plasma	2233002	Class II	Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.	OneBlood, Inc.
Devices	Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5" (37 cm) long The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.	Catalog Number 4934	Class II	During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.	Terumo Cardiovascular Systems Corporation
Devices	Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5" (37 cm) long, with X Coating The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.	Catalog Number 4934X	Class II	During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.	Terumo Cardiovascular Systems Corporation
Devices	Sarns Malleable Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" connector, 15" (38 cm) long The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.	Catalog Number 4935	Class II	During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.	Terumo Cardiovascular Systems Corporation
Devices	Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connector, 15" (38 cm) long The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.	Catalog Number 4936	Class II	During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.	Terumo Cardiovascular Systems Corporation
Devices	Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connector, 15" (38 cm) long, with X Coating The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.	Catalog Number 4936X	Class II	During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.	Terumo Cardiovascular Systems Corporation
Devices	Sarns Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" flare The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.	Catalog Number 16472	Class II	During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.	Terumo Cardiovascular Systems Corporation
Devices	Sarns Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" flare The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.	Catalog Number 16473	Class II	During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.	Terumo Cardiovascular Systems Corporation
Devices	Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when shaken -Not breathing normally If in doubt, apply the pads. A training class in CPR/AED use is recommended for anyone who may use the HS1. If the person is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), use the special infant/child pads. If the child appears older/larger, use the adult pads. Do not delay treatment to determine the child s exact age or weight. If in doubt, use the adult pads. Models M5066A (for HS1 Onsite), M5067A (OnSite) , and M5068A (for HS1 Home).	SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE USA: A13G-00001, A13G-00002, A13G-00003, A13G-00004, A13G-00005, A13G-00006, A13G-00007, A13G-00008, A13G-00009, A13G-00010, A13G-00011, A13G-00012, A13G-00013, A13G-00014, A13G-00015, A13G-00016, A13G-00017, A13G-00018, A13G-00019, A13G-00020, A13G-00021, A13G-00022, A13G-00023, A13G-00024, A13G-00025, A13G-00026, A13G-00027, A13G-00028, A13G-00029, A13G-00030, A13G-00031, A13G-00032, A13G-00033, A13G-00034, A13G-00035, A13G-00036, A13G-00037, A13G-00038, A13G-00039, A13G-00040, A13G-00041, A13G-00042, A13G-00043, A13G-00044, A13G-00045, A13G-00046, A13G-00047, A13G-00048, A13G-00049, A13G-00050, A13G-00051, A13G-00052, A13G-00053, A13G-00054, A13G-00055, A13G-00056, A13G-00057, A13G-00058, A13G-00059, A13G-00060, A13G-00061, A13G-00062, A13G-00063, A13G-00064, A13G-00065, A13G-00067, A13G-00068, A13G-00069, A13G-00070, A13G-00071, A13G-00072, A13G-00073, A13G-00074, A13G-00075, A13G-00076, A13G-00077, A13G-00078, A13G-00079, A13G-00080, 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A13G-00851, A13G-00852, A13G-00853, A13G-00854, A13G-00855, A13G-00856, A13G-00859, A13G-00860, A13G-00861, A13G-00862, A13G-00863, A13G-00865, A13G-00870, A13G-00874, A13G-00875, A13G-00877, A13G-00878, A13G-00880, A13G-00881, A13G-00883, A13G-00884, A13G-00885, A13G-00886, A13G-00887, A13G-00889, A13G-00891, A13G-00892, A13G-00894, A13G-00896, A13G-00897, A13G-00898, A13G-00899, A13G-00900, A13G-00902, A13G-00903, A13G-00904, A13G-00905, A13G-00906, A13G-00907, A13G-00908, A13G-00909, A13G-00910, A13G-00911, A13G-00912, A13G-00913, A13G-00914, A13G-00915, A13G-00916, A13G-00917, A13G-00918, A13G-00919, A13G-00920, A13G-00921, A13G-00922, A13G-00923, A13G-00924, A13G-00925, A13G-00927, A13G-00928, A13G-00929, A13G-00930, A13G-00931, A13G-00932, A13G-00933, A13G-00934, A13G-00935, A13G-00936, A13G-00937, A13G-00938, A13G-00939, A13G-00940, A13G-00943, A13G-00944, A13G-00945, A13G-00946, A13G-00947, A13G-00948, A13G-00949, A13G-00950, A13G-00951, A13G-00952, A13G-00953, A13G-00954, 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A13G-03685, A13G-03686, A13G-03687, A13G-03688, A13G-03689, A13G-03690, A13G-03691, A13G-03692, A13G-03693, A13G-03694, A13G-03695, A13G-03696, A13G-03697, A13G-03698, A13G-03699, A13G-03700, A13G-03701, A13G-03702, A13G-03703, A13G-03704, A13G-03706, A13G-03707, A13G-03708, A13G-03709, A13G-03710, A13G-03711, A13G-03712, A13G-03713, A13G-03714, A13G-03715, A13G-03716, A13G-03717, A13G-03718, A13G-03719, A13G-03720, A13G-03721, A13G-03722, A13G-03723, A13G-03724, A13G-03725, A13G-03726, A13G-03727, A13G-03728, A13G-03730, A13G-03731, A13G-03732, A13G-03733, A13G-03734, A13G-03735, A13G-03737, A13G-03738, A13G-03739, A13G-03740, A13G-03741, A13G-03742, A13G-03743, A13G-03744, A13G-03745, A13G-03746, A13G-03747, A13G-03748, A13G-03749, A13G-03751, A13G-03752, A13G-03753, A13G-03754, A13G-03755, A13G-03756, A13G-03757, A13G-03758, A13G-03759, A13G-03760, A13G-03761, A13G-03762, A13G-03763, A13G-03764, A13G-03765, A13G-03766, A13G-03767, A13G-03768, A13G-03769, A13G-03770, A13G-03771, A13G-03777, A13G-03778, A13G-03779, A13G-03780, A13G-03781, A13G-03782, A13G-03783, A13G-03784, A13G-03785, A13G-03786, A13G-03787, A13G-03788, A13G-03789, A13G-03790, A13G-03791, A13G-03793, A13G-03794, A13G-03795, A13G-03796, A13G-03797, A13G-03798, A13G-03799, A13G-03800, A13G-03801, A13G-03802, A13G-03804, A13G-03805, A13G-03806, A13G-03807, A13G-03808, A13G-03809, A13G-03810, A13G-03811, A13G-03812, A13G-03813, A13G-03814, A13G-03815, A13G-03816, A13G-03817, A13G-03818, A13G-03819, A13G-03820, A13G-03821, A13G-03822, A13G-03823, A13G-03824, A13G-03825, A13G-03826, A13G-03827, A13G-03828, A13G-03829, A13G-03830, A13G-03831, A13G-03832, A13G-03833, A13G-03834, A13G-03835, A13G-03836, A13G-03837, A13G-03838, A13G-03839, A13G-03840, A13G-03841, A13G-03842, A13G-03843, A13G-03844, A13G-03845, A13G-03850, A13G-03852, A13G-03853, A13G-03854, A13G-03855, A13G-03856, A13G-03857, A13G-03858, A13G-03859, A13G-03860, A13G-03861, A13G-03862, A13G-03863, A13G-03864, A13G-03871, A13G-03872, A13G-03874, A13G-03877, A13G-03878, A13G-03879, A13G-03880, A13G-03881, A13G-03882, A13G-03885, A13G-03886, A13G-03887, A13G-03888, A13G-03889, A13G-03890, A13G-03891, A13G-03909, A13G-03911, A13G-03914, A13G-03915, A13G-03916, A13G-03917, A13G-03918, A13G-03923, A13G-03924, A13G-03926, A13G-03927, A13G-03928, A13G-03929, A13G-03931, A13G-03937, A13G-03941, A13G-03943, A13G-03944, A13G-03949, A13G-03953, A13G-03954, A13G-03962, A13G-04029, A13G-04034, A13G-04036, A13G-04049, A13G-04050, A13G-04051, A13G-04056, A13G-04057, A13G-04059, A13G-04062, A13G-04066, A13G-04088, A13G-04089, A13G-04090, A13G-04092, A13G-04115, A13G-04116, A13G-04117, A13G-04118, A13G-04119, A13G-04123, A13G-04124, A13G-04207, A13G-04208, A13G-04209, A13G-04210, A13G-04211, A13G-04212, A13G-04213, A13G-04214, A13G-04220, A13G-04221, A13G-04222, A13G-04223, A13G-04224, A13G-04225, A13G-04227, A13G-04228, A13G-04230, A13G-04232, A13G-04233, A13G-04235, A13G-04238, A13G-04242, A13G-04243, A13G-04244, A13G-04245, A13G-04246, A13G-04247, A13G-04248, A13G-04249, A13G-04250, A13G-04251, A13G-04252, A13G-04256, A13G-04259, A13G-04260, A13G-04261, A13G-04262, A13G-04263, A13G-04264, A13G-04265, A13G-04266, A13G-04267, A13G-04268, A13G-04269, A13G-04270, A13G-04271, A13G-04273, A13G-04282, A13G-04297, A13G-04298, A13G-04299, A13G-04300, A13G-04301, A13G-04302, A13G-04303, A13G-04304, A13G-04305, A13G-04306, A13G-04307, A13G-04308, A13G-04309, A13G-04310, A13G-04311, A13G-04312, A13G-04313, A13G-04314, A13G-04315, A13G-04316, A13G-04317, A13G-04318, A13G-04319, A13G-04320, A13G-04321, A13G-04323, A13G-04324, A13G-04325, A13G-04326, A13G-04332, A13G-04333, A13G-04335, A13G-04336, A13G-04337, A13G-04338, A13G-04339, A13G-04340, A13G-04341, A13G-04342, A13G-04344, A13G-04345, A13G-04346, A13G-04347, A13G-04348, A13G-04349, A13G-04362, A13G-04363, A13G-04364, A13G-04365, A13G-04366, A13G-04369, A13G-04370, A13G-04371, A13G-04372, A13G-04374, A13G-04375, A13G-04376, A13G-04377, A13G-04378, A13G-04379, A13G-04380, A13G-04381, A13G-04382, A13G-04383, A13G-04384, A13G-04385, A13G-04386, A13G-04387, A13G-04388, A13G-04389, A13G-04390, A13G-04391, A13G-04392, A13G-04393, A13G-04394, A13G-04395, A13G-04396, A13G-04397, A13G-04398, A13G-04399, A13G-04401, A13G-04402, A13G-04403, A13G-04404, A13G-04405, A13G-04406, A13G-04407, A13G-04408, A13G-04409, A13G-04410, A13G-04411, A13G-04412, A13G-04414, A13G-04415, A13G-04416, A13G-04417, A13G-04418, A13G-04419, A13G-04421, A13G-04422, A13G-04423, A13G-04424, A13G-04425, A13G-04426, A13G-04427, A13G-04428, A13G-04429, A13G-04430, A13G-04431, A13G-04432, A13G-04433, A13G-04434, A13G-04435, A13G-04436, A13G-04437, A13G-04438, A13G-04439, A13G-04440, A13G-04441, A13G-04442, A13G-04443, A13G-04444, A13G-04445, A13G-04446, A13G-04447, A13G-04448, A13G-04449, A13G-04450, A13G-04451, A13G-04452, A13G-04453, A13G-04454, A13G-04455, A13G-04456, A13G-04457, A13G-04458, A13G-04460, A13G-04462, A13G-04463, A13G-04464, A13G-04465, A13G-04466, A13G-04467, A13G-04468, A13G-04469, A13G-04473, A13G-04474, A13G-04475, A13G-04476, A13G-04477, A13G-04483, A13G-04484, A13G-04485, A13G-04486, A13G-04487, A13G-04488, A13G-04489, A13G-04490, A13G-04491, A13G-04493, A13G-04495, A13G-04496, A13G-04497, A13G-04498, A13G-04501, A13G-04502, A13G-04503, A13G-04504, A13G-04505, A13G-04506, A13G-04507, A13G-04508, A13G-04510, A13G-04511, A13G-04512, A13G-04513, A13G-04514, A13G-04515, A13G-04516, A13G-04517, A13G-04518, A13G-04519, A13G-04520, A13G-04521, A13G-04522, A13G-04525, A13G-04526, A13G-04527, A13G-04528, A13G-04529, A13G-04530, A13G-04531, A13G-04532, A13G-04533, A13G-04534, A13G-04535, A13G-04536, A13G-04537, A13G-04538, A13G-04539, A13G-04540, A13G-04541, A13G-04542, A13G-04543, A13G-04544, A13G-04545, A13G-04546, A13G-04547, A13G-04548, A13G-04549, A13G-04551, A13G-04552, A13G-04553, A13G-04554, A13G-04555, A13G-04556, A13G-04561, A13G-04562, A13G-04563, A13G-04565, A13G-04567, A13G-04568, A13G-04569, A13G-04570, A13G-04571, A13G-04572, A13G-04573, A13G-04574, A13G-04575, A13G-04593, A13G-04594, A13G-04595, A13G-04601, A13G-04602, A13G-04603, A13G-04604, A13G-04605, A13G-04606, A13G-04607, A13G-04609, A13G-04610, A13G-05031, A13G-05034, A13G-05035, A13G-05055, A13G-05057, A13G-05059, A13G-05067, A13G-05068, A13G-05069, A13G-05070, A13G-05071, A13G-05073, A13G-05081, A13G-05082, A13G-05083, A13G-05084, A13G-05085, A13G-05090, A13G-05151, A13G-05152, A13G-05153, A13G-05154, A13G-05155, A13G-05156, A13G-05157, A13G-05158, A13G-05160, A13G-05161, A13G-05162, A13G-05163, A13G-05164, A13G-05165, A13G-05166, A13G-05167, A13G-05168, A13G-05169, A13G-05170, A13G-05171, A13G-05172, A13G-05173, A13G-05174, A13G-05180, A13G-05197, A13G-05198, A13G-05199, A13G-05201, A13G-05202, A13G-05203, A13G-05205, A13G-05212, A13G-05214, A13G-05215, A13G-05218, A13G-05221, A13G-05224, A13G-05225, A13G-05227, A13G-05228, A13G-05229, A13G-05230, A13G-05234, A13G-05235, A13G-05236, A13G-05237, A13G-05238, A13G-05239, A13G-05242, A13G-05246, A13G-05247, A13G-05250, A13G-05252, A13G-05253, A13G-05256, A13G-05257, A13G-05261, A13G-05262, A13G-05269, A13G-05270, A13G-05286, A13G-05288, A13G-05290, A13G-05291, A13G-05294, A13G-05296, A13G-05301, A13G-05308, A13G-05312, A13G-05313, A13G-05314, A13G-05316, A13G-05319, A13G-05321, A13G-05322, A13G-05326, A13G-05328, A13G-05329, A13G-05330, A13G-05331, A13G-05334, A13G-05336, A13G-05342, A13G-05343, A13G-05344, A13G-05346, A13G-05347, A13G-05349, A13G-05364, A13G-05365, A13G-05366, A13G-05367, A13G-05372, A13G-05374, A13G-05375, A13G-05386, A13G-05387, A13G-05388, A13G-05389, A13G-05390, A13G-05392, A13G-05393, A13G-05394, A13G-05395, A13G-05396, A13G-05397, A13G-05398, A13G-05406, A13G-05408, A13G-05409, A13G-05410, A13G-05411, A13G-05412, A13G-05420, A13G-05423, A13G-05427, A13G-05428, A13G-05429, A13G-05450, A13G-05451, A13G-05452, A13G-05454, A13G-05455, A13G-05460, A13G-05476, A13G-05489, A13G-05491, A13G-05495, A13G-05496, A13G-05497, A13G-05498, A13G-05499, A13G-05500, A13G-05501, A13G-05502, A13G-05503, A13G-05504, A13G-05507, A13G-05520, A13G-05521, A13G-05522, A13G-05524, A13G-05525, A13G-05526, A13G-05527, A13G-05528, A13G-05545, A13G-05550, A13G-05551, A13G-05552, A13G-05555, A13G-05556, A13G-05557, A13G-05558, A13G-05559, A13G-05560, A13G-05561, A13G-05562, A13G-05563, A13G-05564, A13G-05565, A13G-05566, A13G-05567, A13G-05568, A13G-05569, A13G-05570, A13G-05571, A13G-05572, A13G-05573, A13G-05574, A13G-05575, A13G-05576, A13G-05577, A13G-05578, A13G-05589, A13G-05622, A13G-05623, A13G-05624, A13G-05625, A13G-05626, A13G-05627, A13G-05628, A13G-05629, A13G-05630, A13G-05631, A13G-05634, A13G-05635, A13G-05636, A13G-05637, A13G-05638, A13G-05639, A13G-05640, A13G-05642, A13G-05643, A13G-05644, A13G-05645, A13G-05646, A13G-05647, A13G-05648, A13G-05649, A13G-05732, A13G-05733, A13G-05734, A13G-05735, A13G-05736, A13G-05738, A13G-05739, A13G-05740, A13G-05741, A13G-05742, A13G-06169, A13G-06170, A13G-06171, A13G-06174, A13G-06175, A13G-06176, A13G-06198, A13G-06213, A13G-06214, A13G-06250, A13G-06251, A13G-06252, A13G-06253, A13G-06254, A13G-06255, A13G-06256, A13G-06257, A13G-06258, A13G-06311, A13G-06312, A13G-06313, A13G-06314, A13G-06315, A13G-06316, A13G-06317, A13G-06439, A13G-06440, A13G-06441, A13G-06442, A13G-06443, A13G-06446, A13G-06447, A13G-06448, A13G-06449, A13G-06450, A13G-06451, A13G-06452, A13G-06453, A13G-06455, A13G-06456, A13G-06458, A13G-06461, A13G-06462, A13G-06531, A13G-06534, A13G-06535, A13G-06536, A13G-06537, A13G-06538, A13G-06540, A13G-06541, A13G-06542, A13G-06546, A13G-06547, A13G-06548, A13G-06549, A13G-06551, A13G-06552, A13G-06553, A13G-06555, A13G-06557, A13G-06558, A13G-06559, A13G-06560, A13G-06561, A13G-06562, A13G-06564, A13G-06566, A13G-06567, A13G-06568, A13G-06569, A13G-06570, A13G-06571, A13G-06572, A13G-06573, A13G-06574, A13G-06575, A13G-06576. SERIAL NUMBERS OF UNITS DISTRIBUTED OUTSIDE THE USA: A13G-00066, A13G-00094, A13G-00113, A13G-00191, A13G-00203, A13G-00205, A13G-00206, A13G-00207, A13G-00208, A13G-00209, A13G-00210, A13G-00211, A13G-00212, A13G-00213, A13G-00214, A13G-00216, A13G-00217, A13G-00218, A13G-00219, A13G-00220, A13G-00221, A13G-00224, A13G-00225, A13G-00226, A13G-00227, A13G-00228, A13G-00229, A13G-00230, A13G-00231, A13G-00232, A13G-00233, A13G-00234, A13G-00235, A13G-00236, A13G-00237, A13G-00238, A13G-00239, A13G-00240, A13G-00241, A13G-00242, A13G-00243, A13G-00246, A13G-00247, A13G-00248, A13G-00249, A13G-00250, A13G-00251, A13G-00252, A13G-00253, A13G-00254, A13G-00255, A13G-00256, A13G-00257, A13G-00266, A13G-00267, A13G-00268, A13G-00269, A13G-00270, A13G-00271, A13G-00272, A13G-00273, A13G-00274, A13G-00275, A13G-00276, A13G-00278, A13G-00279, A13G-00280, A13G-00281, A13G-00282, A13G-00283, A13G-00284, A13G-00285, A13G-00286, A13G-00287, A13G-00290, A13G-00291, A13G-00292, A13G-00293, A13G-00295, 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A13G-04808, A13G-04809, A13G-04810, A13G-04811, A13G-04812, A13G-04813, A13G-04815, A13G-04816, A13G-04817, A13G-04818, A13G-04819, A13G-04820, A13G-04821, A13G-04822, A13G-04823, A13G-04824, A13G-04825, A13G-04826, A13G-04827, A13G-04828, A13G-04829, A13G-04830, A13G-04831, A13G-04832, A13G-04833, A13G-04834, A13G-04835, A13G-04836, A13G-04837, A13G-04838, A13G-04839, A13G-04840, A13G-04841, A13G-04842, A13G-04843, A13G-04844, A13G-04845, A13G-04846, A13G-04847, A13G-04848, A13G-04849, A13G-04850, A13G-04851, A13G-04852, A13G-04853, A13G-04854, A13G-04855, A13G-04856, A13G-04857, A13G-04858, A13G-04859, A13G-04860, A13G-04861, A13G-04862, A13G-04863, A13G-04864, A13G-04865, A13G-04866, A13G-04867, A13G-04868, A13G-04869, A13G-04870, A13G-04871, A13G-04872, A13G-04873, A13G-04874, A13G-04875, A13G-04876, A13G-04877, A13G-04878, A13G-04879, A13G-04881, A13G-04882, A13G-04883, A13G-04884, A13G-04885, A13G-04886, A13G-04887, A13G-04888, A13G-04889, A13G-04890, A13G-04892, A13G-04893, A13G-04894, A13G-04895, A13G-04896, A13G-04897, A13G-04901, A13G-04902, A13G-04903, A13G-04904, A13G-04906, A13G-04907, A13G-04908, A13G-04909, A13G-04910, A13G-04911, A13G-04912, A13G-04913, A13G-04914, A13G-04915, A13G-04916, A13G-04917, A13G-04918, A13G-04919, A13G-04920, A13G-04921, A13G-04922, A13G-04923, A13G-04924, A13G-04951, A13G-04952, A13G-04953, A13G-04954, A13G-04955, A13G-04956, A13G-04957, A13G-04958, A13G-04959, A13G-04960, A13G-04961, A13G-04962, A13G-04963, A13G-04964, A13G-04965, A13G-04966, A13G-04967, A13G-04968, A13G-04969, A13G-04970, A13G-04971, A13G-04974, A13G-04975, A13G-04976, A13G-04977, A13G-04978, A13G-04980, A13G-04983, A13G-04985, A13G-04987, A13G-04988, A13G-04989, A13G-04990, A13G-04993, A13G-04996, A13G-04997, A13G-04999, A13G-05000, A13G-05001, A13G-05002, A13G-05003, A13G-05004, A13G-05005, A13G-05007, A13G-05008, A13G-05009, A13G-05010, A13G-05011, A13G-05012, A13G-05013, A13G-05014, A13G-05015, A13G-05016, A13G-05017, A13G-05019, A13G-05020, A13G-05021, A13G-05023, A13G-05024, A13G-05025, A13G-05030, A13G-05041, A13G-05042, A13G-05043, A13G-05044, A13G-05045, A13G-05046, A13G-05047, A13G-05048, A13G-05049, A13G-05050, A13G-05051, A13G-05053, A13G-05054, A13G-05060, A13G-05061, A13G-05063, A13G-05064, A13G-05065, A13G-05076, A13G-05078, A13G-05079, A13G-05080, A13G-05086, A13G-05087, A13G-05088, A13G-05089, A13G-05091, A13G-05092, A13G-05093, A13G-05094, A13G-05095, A13G-05096, A13G-05097, A13G-05098, A13G-05099, A13G-05100, A13G-05101, A13G-05102, A13G-05103, A13G-05104, A13G-05105, A13G-05106, A13G-05107, A13G-05108, A13G-05109, A13G-05110, A13G-05111, A13G-05112, A13G-05113, A13G-05114, A13G-05115, A13G-05116, A13G-05118, A13G-05119, A13G-05120, A13G-05121, A13G-05122, A13G-05123, A13G-05124, A13G-05125, A13G-05127, A13G-05128, A13G-05129, A13G-05130, A13G-05131, A13G-05132, A13G-05133, A13G-05134, A13G-05136, A13G-05137, A13G-05138, A13G-05139, A13G-05140, A13G-05141, A13G-05142, A13G-05143, A13G-05144, A13G-05145, A13G-05146, A13G-05147, A13G-05148, A13G-05149, A13G-05150, A13G-05159, A13G-05175, A13G-05181, A13G-05182, A13G-05184, A13G-05185, A13G-05186, A13G-05187, A13G-05188, A13G-05192, A13G-05193, A13G-05194, A13G-05195, A13G-05207, A13G-05208, A13G-05209, A13G-05210, A13G-05211, A13G-05213, A13G-05220, A13G-05222, A13G-05226, A13G-05231, A13G-05232, A13G-05241, A13G-05249.	Class II	Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) because one or both contact pins may be contaminated by residue from the soldering process. This contamination could prevent an adequate connection between the pads cartridge and the AED. If poor contact between the pads cartridge and AED occurs, the device may be unable to deliver therapy in an emergency.	Philips Medical Systems North America Inc.
Drugs	Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940 USA. NDC 0573-0164-43	G85041	Class III	Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.	Pfizer Us Pharmaceutical Group
Devices	Part 475620 Intramedullary Bone Saw CAM Assembly Size 12mm, A unique and exclusive clinical instrument used to correct leg length, or rotational discrepancies in the femur.	Lot 669420	Class II	Incorrect labeling on specific lots of the Intramedullary Bone Saw.The Saw Blade Assembly was identified as CAM Assembly.	Biomet, Inc.
Devices	Part 475625, Intramedullary Bone Saw, Cam Assembly Size 13 mm, The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.	Lot 239430, 239450	Class II	Incorrect labeling on specific lots of the Intramedullary Bone Saw. The Saw Blade Assembly was identified as CAM Assembly.	Biomet, Inc.
Devices	Part 475630, Intramedullary Bone Saw, Cam Assembly Size 14 mm, The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.	Lot 239470, 457450	Class II	Incorrect labeling on specific lots of the Intramedullary Bone Saw. The Saw Blade Assembly was identified as CAM Assembly.	Biomet, Inc.
Devices	Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389. The HeartStart FR3 is a battery powered automated external defibrillator (AED) designed for use by responders who have been trained in Basic Life Support (BLS), Advanced Life Support (ALS), or another physician-authorized emergency medical response program. The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardia (VTs). Both models are used with disposable defibrillator pads applied to potential victims of SCA with the following symptoms: -Unresponsiveness -Absence of normal breathing If in doubt, apply the pads. The HeartStart FR3 is intended for adults and children over 55 pounds (25 kg) or 8 years old. Both models 861388 and 861389 are also intended for children under 55 pounds (25 kg) or 8 years old when used with the optional Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child's age or weight, do not delay treatment.	Serial numbers of units distributed in the USA: C13A-00592, C13C-00131, C13C-00150, C13C-00270, C13C-00679, C13C-00681, C13C-00769, C13D-00048, C13D-00197, C13E-00088, C13E-00168, C13E-00234, C13E-00242, C13E-00245, C13E-00326, C13E-00340, C13E-00368, C13E-00372, C13E-00380, C13E-00382, C13E-00390, C13E-00406, C13E-00495, C13E-00507, C13E-00511, C13E-00516, C13E-00526, C13E-00537, C13F-00011, C13F-00012, C13F-00013, C13F-00022, C13F-00024, C13F-00027, C13F-00031, C13F-00032, C13F-00033, C13F-00035, C13F-00038, C13F-00043, C13F-00047, C13F-00053, C13F-00054, C13F-00059, C13F-00071, C13F-00077, C13F-00078, C13F-00102, C13F-00104, C13F-00110, C13F-00114, C13F-00118, C13F-00126, C13F-00131, C13F-00137, C13F-00138, C13F-00140, C13F-00143, C13F-00146, C13F-00148, C13F-00168, C13F-00172, C13F-00173, C13F-00174, C13F-00180, C13F-00181, C13F-00198, C13F-00202, C13F-00212, C13F-00214, C13F-00215, C13F-00217, C13F-00218, C13F-00224, C13F-00225, C13F-00227, C13F-00232, C13F-00233, C13F-00236, C13F-00238, C13F-00239, C13F-00240, C13F-00244, C13F-00246, C13F-00250, C13F-00255, C13F-00266, C13F-00273, C13F-00274, C13F-00275, C13F-00278, C13F-00284, C13F-00291, C13F-00294, C13F-00307, C13F-00309, C13F-00318, C13F-00321, C13F-00322, C13F-00323, C13F-00329, C13F-00330, C13F-00331, C13F-00332, C13F-00336, C13F-00348, C13F-00353, C13F-00468, C13F-00543, C13F-00559, C13F-00567, C13F-00578, C13F-00590, C13F-00593, C13F-00595, C13F-00599, C13F-00604, C13F-00607, C13F-00651, C13F-00778, C13G-00008, C13G-00010, C13G-00035, C13G-00056, C13G-00057, C13G-00282, C13G-00284, and C13H-00062. Serial numbers of units outside the USA: C13C-00004, C13C-00256, C13C-00305, C13C-00323, C13C-00608, C13C-00639, C13E-00009, C13E-00021, C13E-00036, C13E-00048, C13E-00057, C13E-00058, C13E-00065, C13E-00163, C13E-00250, C13E-00265, C13E-00273, C13E-00311, C13E-00323, C13E-00328, C13E-00339, C13E-00341, C13E-00345, C13E-00346, C13E-00349, C13E-00350, C13E-00351, C13E-00358, C13E-00393, C13E-00395, C13E-00404, C13E-00407, C13E-00409, C13E-00424, C13E-00437, C13E-00441, C13E-00452, C13E-00454, C13E-00455, C13E-00499, C13E-00503, C13E-00518, C13E-00527, C13E-00535, C13E-00548, C13F-00010, C13F-00280, C13F-00286, C13F-00293, C13F-00298, C13F-00302, C13F-00303, C13F-00305, C13F-00306, C13F-00316, C13F-00317, C13F-00343, C13F-00345, C13F-00346, C13F-00358, C13F-00363, C13F-00369, C13F-00371, C13F-00381, C13F-00385, C13F-00391, C13F-00400, C13F-00420, C13F-00424, C13F-00428, C13F-00436, C13F-00473, C13F-00498, C13F-00539, C13F-00565, C13F-00579, C13F-00580, C13F-00583, C13F-00586, C13F-00587, C13F-00606, C13F-00619, C13F-00627, C13F-00629, C13F-00649, C13F-00666, C13F-00668, C13F-00677, C13F-00678, C13F-00682, C13F-00685, C13F-00687, C13F-00726, C13F-00742, C13F-00746, C13F-00748, C13F-00755, C13F-00758, C13F-00760, C13F-00782, C13F-00797, C13F-00815, C13F-00870, C13F-00889, C13F-00896, C13F-00938, C13G-00026, C13G-00039, C13G-00084, C13G-00126, C13G-00132, C13G-00142, C13G-00237, C13G-00247, C13G-00293, C13G-00315, C13G-00331, C13G-00337, C13G-00345, C13G-00407, C13G-00435, C13G-00451, and C13H-00035.	Class II	Philip's is recalling HeartStart FR3 Automated External Defibrillator (AED) because the Printed Circuit Board (PCB), which contains the circuitry that supplies energy to the device, could become separated from the electrical contact points that hold the board in place. In the event the PCB becomes separated from the electrical contact points, the AED may not be ready to deliver a shock in the event of an emergency.	Philips Medical Systems North America Inc.
Devices	Rusch Brochopart and Rusch Brochopart White The Rush Endobronchial Tube set is indicated for uses commonly associated with oral endobronchial tubes, including, but not limited to, thoracic surgery, bronchospirometry, administration of endobronchial anesthesia, etc. The endobronchial tube allows ventilation and selective inflation or deflation of either lung.	Product Code - 116200260, Batch 09LE51, 10GE31, 11LE42, 12DE17, 12IE37, 13CT26, 13DT32; Product Code - 116200280 - Batch 09HE34, 09JE41, 10BE07, 11HE33, 11JE41, 13ET12; Product Code - 116200350 - Batch 0918M, 0915M, 09JE43, 09JE42, 0917M, 11AE03, 11DE15, 11GE27, 09HE34, 11JE43, 11JE42, 12AE02, 12BE07, 12DE17, 12EE19, 12GE27, 12HE33, 13AE01, 13CT26, 13DT33, 13ET12; Product Code 116200370 - Batch 0915M, 0917M, 0914M, 09JE41, 09JE43, 11DE15, 11EE20, 11GE27, 11JE42, 11HE32, 11JE43, 11IE39, 12AE01, 12AE03, 12GE31, 12BE06, 12DE18, 12IE39, 12JE44, 13AT44, 13BT44, 13AE01, 12LE49, 13DT33; Product Code 116200390 - Batch 0914M, 0922M, 0917M, 09JE44, 09FE23, 09HE35, 09JE42, 10GE29, 10AE02, 09JE43, 09KE46, 09LE51, 10AE01, 10CE11, 10DE18, 10EE19, 10JE41, 10EE20, 11DE15, 11KE42, 11GE30, 11HH33, 11IE37, 11IE38, 11IE39, 13AT36, 13BT25, 13BT29; Product Code 116200410 - Batch 0922M, 0915M, 0918M, 09IE36, 09JE43, 10AE05, 10BE06, 10DE16, 10GE28, 10JE41, 11DE15, 11GE27, 11HE34, 11JE43, 13BT44, 13DT32; Product Code 116201350 - Batch 0921M, 09JE40, 09FE23, 13GT05; Product Code 116201370 - Batch 0922M, 0915M, 13AE01, 13ET18, 13HT12, 09FE24; Product Code 116201390 - Batch 09JE44, 10CE10; Product Code 116201410 - Batch 10KE47	Class II	The product may fail to achieve seal of right lung due to the cuff inflating to one side	Teleflex Medical
Drugs	Guaifenesin USP, 50 Kg Drums, CAS No. 93-14-1, Reg. No. 05436, Caution: For Manufacturing, Processing, or Repacking, Delta Synthetic Co., Ltd. 15, Minsheng St., Tucheng Dist., New Taipei City, 23679, Taiwan (ROC), NDC 60203-1001	211J3291 211J3292 211K3293 211K3294 211K3295 211K3297 211K3298 211K3299 211K3301 211K3302 211K3315 211K3321 211K3322	Class II	Presence of Foreign Matter: Guaifenesin API powder is being recalled due to the possibility that the product contains polyethylene fibers from a screen used to sift the Guaifenesin.	Traxx International Corp
Food	Starbuck's brand Greek Yogurt Raspberry & Lemon Parfait; 6.1 oz single serve plastic cups, sold as individual unit. Finished product label is affixed to the top of the cup; nutritional labeling is located on the side of the cup, along with the printed code which appears on a white sticky label. UPC 6211198649.	"Enjoy by 03 05", which represents March 5th, 2014.	Class I	Gretchen's Shoebox Express is recalling Greek Yogurt Raspberry & Lemon Parfait cups sold under the Starbucks brand due to undeclared egg.	Gretchen's Shoebox Express
Devices	Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206 EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of Doppler velocity results values are used to assist in diagnosing the existence, location and severity of cardiac or vasculare stenosis.	All systems below software v1.1.2 Which includes software v1 and v 1.1 (All lot codes shipped prior to 2/28/2014).	Class II	A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System. The system will report incorrect Doppler velocities if you use High Pulse Repetition Frequency (HPRF) with multiple sample volume gates. While in High Pulse Repetition Frequency (HPRF) in Display Zoom Velocity Scale using manual spectral Doppler trace, the velocities in the velocity results table may be overstated by 25-75%, depending on the scale value.	Philips Medical Systems North America Inc.
Devices	Philips Model EPIQ 7 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206 EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of Doppler velocity results values are used to assist in diagnosing the existence, location and severity of cardiac or vasculare stenosis.	All systems below software v1.1.2 Which includes software v1 and v 1.1 (All lot codes shipped prior to 2/28/2014).	Class II	A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System. The system will report incorrect Doppler velocities if you use High Pulse Repetition Frequency (HPRF) with multiple sample volume gates. While in High Pulse Repetition Frequency (HPRF) in Display Zoom Velocity Scale using manual spectral Doppler trace, the velocities in the velocity results table may be overstated by 25-75%, depending on the scale value.	Philips Medical Systems North America Inc.
Devices	DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 Product Usage: Limb holders are intended for mildly to moderate agitated or disoriented patients who disrupt medical treatment and/or cause harm to themselves and/or others	lot numbers 1143442 and 1161762	Class II	Moldy smell in product	DeRoyal Industries Inc
Devices	Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc; Pleasanton, CA. General ophthalmic imaging including retinal, corneal and external imaging. Photo-documentation of pediatric ocular diseases including retinopathy of prematurity. Screening for Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP.	Lot of Halogan Lamp Component is #020612C. RetCam 3, Part number 21-100500. RetCam 3 affected serial numbers: RC3066 RC3079 RC6013 RC6033 RC6034 RC6035 RC6036 RC6037 RC6038 RC6039 RC6040 RC6041 RC6043 RC6044 RC6045 RC6047 RC6049 RC6050 RC6053 RC6054 RC6055 RC6056 RC6057 RC6058 RC6059 RC6060 RC6063 RC6064 RC6066 RC6067 RC6068 RC6069 RC6070 RC6071 RC6072 RC6073 RC6074 RC6075 RC6076 RC6077 RC6078 RC6079 RC6080 RC6081 RC6082 RC6083 RC6084 RC6085 RC6086 RC6087 RC6088 RC6089 RC6090 RC6092 RC6093 RC6094 RC6095 RC6096 RC6098 RC6099 RC6101 RC6102 RC6103 RC6104 RC6105 RC6106 RC6107 RC6108 RC6109 RC6110 RC6111 RC6112 RC6113 RC6301 RC6302 RC6303 RC6304 RC6305 RC6306 RC6307 RC6309 RC6310 RC6311 RC6312 RC6313 RC6314 RC6315 RC6316 RC6317 RC6318 RC6319 RC6320 RC6321 RC6322 RC6323 RC6324 RC6325 RC6326 RC6327 RC6328 RC6329 RC6330 RC6331 RC6332 RC6333 RC6334 RC6335 RC6336 RC6337 RC6338 RC6339 RC6340 RC6341 RC6342 RC6343 RC6344 RC6364	Class II	One lot of Halogen lamps have the potential to fail sooner than the expected life of the lamp which could result in damage limited to the internal electrical components inside the RetCam 3 computer module.	Clarity Medical Systems Inc
Biologics	Cornea	126688OSC;	Class III	Human cornea, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed.	San Diego Eye Bank
Biologics	Reagent Red Blood Cells	V139824; V139825	Class III	Misbranded Reagent Red Blood Cells were distributed.	Alba Bioscience Limited
Drugs	Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count patches per box, Rx Only. Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5554-3.	Lot #69618, Exp. 09/14	Class II	Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.	Noven Pharmaceuticals, Inc.
Drugs	Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3mg/hr), 1patch per pouch , packaged in 30-count patches per box, Rx Only.Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5555-3.	Lot #70132, Exp. 09/14	Class II	Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.	Noven Pharmaceuticals, Inc.
Food	High Mowing Organic Sprouting Seeds Ancient Eastern Blend , 4 oz. resealable plastic bag UPC Code: 872724005445	Lot code: MUM19-10	Class II	Contains undeclared wheat	High Mowing Organic Seed
Drugs	Perrigo, Clindamycin Palmitate Hydrochloride for Oral Solution, USP, 75mg/5mL, 100 ml, NDC 0574-0129-01	2013313915 Exp 08/15, 2013374398 Exp 09/15, 2013323969 Exp 08/15, 2013364336 Exp 09/15, 2013323971 Exp 08/15, 2013364334 Exp 09/15, 2013313913 Exp 08/15	Class II	Presence of Particulate Matter Perrigo is recalling seven lots of Clindamycin Palmitate Hydrochloride for Oral Solution 75mg/5ml.	Paddock Laboratories, LLC
Drugs	Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets per Box (10 x 10), Rx Only, Manufactured by: Teva Pharmaceuticals USA, 1090 Horsham Rd, North Wales, PA 19454, NDC 63739-0512-10	Lot #: 91357	Class III	Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval.	McKesson Packaging Services

RX south LLC dba RX# Pharmacy--

Drugs

Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution, in 3 ml single dose syringes; a multi-ingredient compounded medication in bulk, containing Benzoyl Benzoate USP 0.46 ml/1ml, and Benzyl Alcohol 0.02 ml/1ml; syringe is labeled in part ***FOR INJECTION USE ONLY***RX South LLC DBA RX3 12230 Iron Bridge Rd Chester, VA 23831***

Lot number: 12052013:03 Expiration date: 06/03/2014

Class II

Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping

RX South LLC DBA RX3 Pharmacy

Hospira, Inc. Particles in vial

Drugs

Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30.

Lot 25-220-DD, Exp 1JAN2015

Class I

Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.

Hospira Inc.

Pain Medicine News - Does Bill Have the Muscle To Stop Another NECC?

Pain Medicine News - Does Bill Have the Muscle To Stop Another NECC?

Oklahoma Told It Can’t Shield Suppliers of Execution Drugs

An Oklahoma judge ruled on Wednesday that the state could not keep secret the identities of the suppliers of lethal-injection drugs, raising doubts about the executions of two prisoners next month and fueling a growing legal battle in several states over secrecy in methods of execution.

The state argued that a supplier-secrecy law, passed in 2011, was necessary because of a shortage of execution drugs and threats against companies that supply them. But lawyers for the two prisoners, Clayton Lockett and Charles Warner, countered that without knowing the source of the drugs, courts could not determine whether the execution protocol satisfied the constitutional ban on cruel and unusual punishment, and prisoners were denied the right to know, and potentially question, how they would be put to death.

Judge Patricia Parrish, of the Oklahoma County District Court, declared the secrecy statute to be an unconstitutional violation of due process in an oral decision from the bench.

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Condemned inmates seek info on lethal drug By Mike Ward, Austin Bureau : March 26, 2014

AUSTIN — Two condemned killers, including a one-time drifter who claimed he killed 70 people in a cross-country crime spree spanning 19 years, have sued state officials to force them to disclose details about the execution drugs that will be used to end their lives.
In a lawsuit filed in Travis County state court, Tommy Lynn Sells, 49, and Ramiro Hernandez Llanes, 44, alleged the Texas Department of Criminal Justice is illegally refusing to provide their attorneys with information about the powerful barbiturate pentobarbital that will be used to execute them, despite earlier court orders and attorney general opinions making that information available to them and the  public.
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IACP Announces It is Tracking 61 pieces of legislation on behalf of IACP Members

IACP RX Hot off the Presses! Click here http://bit.ly/1gYm4zS for today's issue of IACP's Compounders Stateside - Your State Compounding Legislation Tracker. IACP is now monitoring more than 61 pieces of legislation on behalf of IACP Members!

MUST READ!! Weatherford Compounding Pharmacy Inspection Report from Texas Board of Pharmacy

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CVM Updates FDA Receives Strong Industry Commitment for its Antibiotic Resistance Strategy

CVM Updates FDA Receives Strong Industry Commitment for its Antibiotic Resistance Strategy

Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act; Request for Nominations--31 Comments Now Available for Public Viewing

Comment from Biogen Idec, Inc.

• See Attached

• Public Submission
• Posted:
  03/10/2014
• ID:
  FDA-2013-N-1523-0008

• Agency:
  FDA
• RIN:
  Not Assigned
• Docket ID:
  FDA-2013-N-1523

• Organization:
• Submitter Name:

Comment Period Closed

Mar 04, 2014 11:59 PM ET

Comment from Kenneth Woliner, MD

• NOMINATION: Human Chorionic Gonadotropin (hCG) in any dosage form not injectable (i.e. it is "difficult to compound" hCG in oral, sublingual, intranasal, and topical delivery...

• Public Submission
• Posted:
  02/06/2014
• ID:
  FDA-2013-N-1523-0002

• Agency:
  FDA
• RIN:
  Not Assigned
• Docket ID:
  FDA-2013-N-1523

• Organization:
• Submitter Name:

Comment Period Closed

Mar 04, 2014 11:59 PM ET

Comment from the Arachnoidis Society for Awareness and Prevention

• See Attached

• Public Submission
• Posted:
  03/07/2014
• ID:
  FDA-2013-N-1523-0007

• Agency:
  FDA
• RIN:
  Not Assigned
• Docket ID:
  FDA-2013-N-1523

• Organization:
• Submitter Name:

Comment Period Closed

Mar 04, 2014 11:59 PM ET

Comment from AnazaoHealth

• See attached file(s)

• Public Submission
• Posted:
  03/21/2014
• ID:
  FDA-2013-N-1523-0030

• Agency:
  FDA
• RIN:
  Not Assigned
• Docket ID:
  FDA-2013-N-1523

• Organization:
• Submitter Name:

Comment Period Closed

Mar 04, 2014 11:59 PM ET

Comment from Biotechnology Industry Organization (BIO)

• See attached file(s)

• Public Submission
• Posted:
  03/21/2014
• ID:
  FDA-2013-N-1523-0029

• Agency:
  FDA
• RIN:
  Not Assigned
• Docket ID:
  FDA-2013-N-1523

• Organization:
• Submitter Name:

Comment Period Closed

Mar 04, 2014 11:59 PM ET

Comment from PharMEDium Services

• See attached file(s)

• Public Submission
• Posted:
  03/21/2014
• ID:
  FDA-2013-N-1523-0021

• Agency:
  FDA
• RIN:
  Not Assigned
• Docket ID:
  FDA-2013-N-1523

• Organization:
• Submitter Name:

Bulk Drug Substances That May Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act; Request for Nominations--Letters Posted so Far for Public Viewing

Nomination from the Prescription Center re Ammonium Tetrathiomolybdate

• See Attached

• Public Submission
• Posted:
  03/07/2014
• ID:
  FDA-2013-N-1525-0002

• Agency:
  FDA
• RIN:
  Not Assigned
• Docket ID:
  FDA-2013-N-1525

• Organization:
• Submitter Name:

Comment Period Closed

Mar 04, 2014 11:59 PM ET

Nomination from Fagron, Inc., re Carbonyl Iron and Feosol Carbonyl Iron MAE3

FDA Issues Second 483 to Leiter's Cambrian Park Drugs, Inc. dba Leiter's Compounding Pharmacy, San Jose, CA

Leiter's Cambrian Park Drugs, Inc. (dba Leiter's Compounding Pharmacy), San Jose, CA

• 483 Issued 03/06/2014⁶⁶ (PDF - 1.3MB)

FDA Issues Second 483 to Wells Pharmacy Network LLC, Ocala, FL

Wells Pharmacy Network LLC, Ocala, FL

• 483 Issued 03/07/2014¹⁵⁷ (PDF - 1.2MB)

Recall on Bella Vi Dietary Supplement

03/26/2014

Bella Vi

Dietary Supplement

Products contain undeclared Sibutramine and/or combination of Sibutramine and Phenolphthalein

Pure Edge Nutrition, LLC

Consumer Updates FDA Partners With Veterinary Labs to Help Animals

Consumer Updates FDA Partners With Veterinary Labs to Help Animals

FDA to drugmakers: Tell doctors, patients not all drug approvals are permanent

By Virgil Dickson Posted: March 25, 2014 - 3:00 pm ET Tags: Pharmaceuticals, Regulation, Suppliers, Supply Chain, U.S. Food and Drug Administration (FDA) The Food and Drug Administration wants drugmakers to change labeling on drugs approved through the accelerated approval pathway so doctors and patients know such approvals could subsequently be revoked. A new FDA guidance (PDF) seeks to clarify how drugs approved through the accelerated approval pathway should be labeled. The pathway in question is used to expedite the approval of medicines intended to treat serious or unmet needs. For instance, if there is a promising drug for a certain type of cancer that shows some early signs of benefit, that product could receive tentative accelerated approval. continue to read here

Another Compounding Pharmacy Sales Rep Opening

Compounding Pharmacy Sales Rep-With Experience ONLY! (Hallandale)

compensation: Dependent on Experience

telecommuting okay

Compounding Pharmacy in South Florida searching for experienced sales person.
Candidate must have:
1. Experience selling sterile and non-sterile compounded medications
2. Background in Anti-Aging, Hormone Replacement, Pain Management, Dermatology, Erectile Dysfunction
3. Able to travel if necessary and manage clients remotely (through technology)
4. Fluent in English (and Spanish a plus but not required)

Serious Candidates only!
Send by email Resume with "position-your name" in email subject line.

• Location: Hallandale
• Principals only. Recruiters, please don't contact this job poster.
• do NOT contact us with unsolicited services or offers

• Principals only. Recruiters, please don't contact this job poster.
• do NOT contact us with unsolicited services or offers

post id: 4391746346

posted: 21 hours ago

updated: 21 hours ago

Look at all the Compounding topics to be covered at the 110th Annual NABP Meeting

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Must Read! Been There Done It Post on Horse Doping--very telling information

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Interesting Blog Post on the horse doping scandal--the mushy middle

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FDA Recall on Super Fat Burner, Maxi Gold and Esmeralda

03/25/2014

Super Fat Burner, Maxi Gold, and Esmeralda

Dietary Supplement

Unapproved new drug

New Life Nutritional Center

The Ugly Truth About Horse Racing

An exposé by PETA, published in The New York Times, shows a side of the sport that the industry has tried hard to shield from public view. 

Andrew CohenMar 24 2014, 3:31 PM ET

 

There are essentially three types of people in horse racing. There are the crooks who dangerously drug or otherwise abuse their horses, or who countenance such conduct from their agents, and who then dare the industry to come catch them. Then there are the dupes who labor under the fantasy that the sport is broadly fair and honest. And there are those masses in the middle—neither naive nor cheaters but rather honorable souls—who know the industry is more crooked than it ought to be but who still don't do all they can to fix the problem.

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Tom Noonan--Yet Another Wake Up Call for Horse Racing

Posted in: Horse Racing, Political/Social commentary, Politics. Tagged: Lasix, New York Gaming Commission, New York Times, NYRA, PETA, Scott Blasi, Steve Asmussen, The Atlantic, Thoroughbred Racing Commentary. Leave a comment

Racing at Saratoga brings many of the nation’s best horses, trainers and jockeys to the Spa for a 40-day meet in a resort atmosphere.  It also brings industry leaders who participate in the several seminars that take place.  Last year the unifying theme may well have been drugs and the public’s perception of widespread abuse.
At one such session last year, trainer John Kimmel lambasted those who thought that mistreatment of horses was a problem, blaming it on  -  wait for it  -  the media.  He challenged them to go to the backstretch to observe how well the horses are cared for.  Little did he know that as he was speaking, someone was doing just that, armed with a video camera.  This week, the work of the undercover investigator for PETA (People for the Ethical Treatment of Animals) became public courtesy of Joe Drape of The New York Times and PETA’s web site.
According to Drape’s piece, the investigator worked in Steve Asmussen’s barn at Churchill Downs and Saratoga for four months.  It is clear no one was aware they were being recorded.  PETA has filed complaints with ten federal and state agencies based on the investigation, but it is a nine-minute video that has the racing world abuzz.  Among PETA’s allegations are the mistreatment of horses, the use of batteries to shock horses, administration of Lasix as a performance-enhancing drug, and numerous violations of employment laws
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Thought, feelings, observations on Asumussen video scandal

Thought, feelings, observations on Asumussen video scandal

Clean up ‘chemical’ horse racing

It’s time for the U.S. Anti-Doping Agency to step in and clean up the thoroughbred racing industry’s addiction to drugs.
As The New York Times has just reported, over a period of four months, a PETA investigator worked for well-known trainer Steve Asmussen, trainer of Curlin and Rachel Alexandra, at two of the most famous racetracks in America: Churchill Downs in Kentucky and the Saratoga Race Course in New York. PETA’s investigation exposed many serious problems but none more harmful than the routine, pervasive and improper use of prescription drugs during training, a regimen that has begun the downward spiral to the slaughterhouse for thousands of horses.
Fragile young horses — raced before their bones have fully matured and unable to handle the pounding and stress — suffer routinely from injuries, lameness, exhaustion and what is euphemistically called "soreness." Owners don’t want to waste time waiting until foals are physically capable. They want to get the cash flow started.
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India cracks down on same Wockhardt plants FDA has banned

March 24, 2014 | By Eric Palmer

Read more: India cracks down on same Wockhardt plants FDA has banned - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/india-cracks-down-same-wockhardt-plants-fda-has-banned/2014-03-24#ixzz2x09iwbnq
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FDA approves J&J to make bulk Doxil at closed Ben Venue plant

Janssen has another manufacturer finish off the drug as part of an 'alternative' process

March 25, 2014 | By Eric Palmer

Read more: FDA approves J&J to make bulk Doxil at closed Ben Venue plant - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/fda-approves-jj-make-bulk-doxil-closed-ben-venue-plant/2014-03-25#ixzz2x09NMNZN
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Hospira CEO gets nearly $10M for steering drugmaker through issues

F. Michael Ball gets $1.1M boost to total compensation in 2013

March 25, 2014 | By Eric Palmer

Read more: Hospira CEO gets nearly $10M for steering drugmaker through issues - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/hospira-ceo-gets-nearly-10-million-steering-drugmaker-through-issues/2014-03-25#ixzz2x091bwIo
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Pharmacy Law Blog: Out-of-State Compounding Pharmacies May Need a Permit To Do Business in Florida By Lance O. Leider, J.D., The Health Law Firm

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Pharmacists Urged Not to Assist US Executions

Several human rights and anti-death penalty groups have asked the American Pharmacists Association to prohibit members from participating in executions, a request that comes as states increasingly turn to pharmacists for lethal injection drugs.

The groups, which include Amnesty International, the NAACP and the American Civil Liberties Union, are targeting so-called compounded drugs. Such drugs, which are not federally regulated, are individually mixed versions of medications that prison systems are finding increasingly difficult to obtain.

Death  penalty opponents say such drugs put inmates at risk of pain and suffering. Two years ago, an outbreak of meningitis that killed 64 and sickened hundreds was traced to a compounding facility in Massachusetts.

Pharmacists who provide compounded drugs are violating key provisions of the pharmacists' association code of ethics, including helping patients achieve "optimum benefit" from their medications, according to a letter the death penalty opponents presented to the association on Monday.

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Tennessee board adds new rules for compounding pharmacies

Tennessee board adds new rules for compounding pharmacies

Florida House committee passes bill regulating compounding pharmacies

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Warning Letters Smruthi Organics Limited 3/6/14

Warning Letters Smruthi Organics Limited 3/6/14