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High RiskFDA
Aesculap Implant Systems
Columbus Tibia Plateau (component of the Columbus REVISION Knee System) Product Usage - The Columbus Revision Knee System is indicated...
Medical Devices·8 affected·Feb 21, 2012
High RiskFDA
Toshiba American Medical Systems Inc
Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage. MRT-1503/P5-Vantage MRI System. MR imaging.
Medical Devices·3 affected·Feb 21, 2012
High RiskFDA
Physicians Total Care, Inc.
PHYSICIANS TOTAL CARE, TETRACYCLINE, 250 mg, 30 CAPSULES, bottle MFG. BY: TEVA PHARMACEUTICALS USA, SELLERSVILLE PA 18960 NDC 54868-0024-08
Oral Drugs·1,200 affected·Feb 20, 2012
High RiskFDA
Physicians Total Care, Inc.
PHYSICIANS TOTAL CARE, TETRACYCLINE, 500 mg, 30 CAPSULES, bottle MFG. BY: TEVA PHARMACEUTICALS USA, SELLERSVILLE PA 18960 NDC 54868-0025-09
Oral Drugs·3,660 affected·Feb 20, 2012
High RiskFDA
Vital Signs Devices, A Ge Healthcare Company
enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, M...
Medical Devices·11,803 affected·Feb 20, 2012
High RiskFDA
Sunshine Peanut Company
Sunny Boy Peanut Butter. Product is labeled in part: 6/5 lb tubs- "SunnyBoy Creamy PEANUT BUTTER***Net Wt. 5lb. (2.27KG)***INGREDIENT...
Dairy·72 affected·Feb 17, 2012
High RiskFDA
Sunshine Peanut Company
Product is 1 oz Peanut Butter. 1 oz pouch labeled in part: "PEANUT BUTTER***Ingredients: Roaster Peanuts, Sugar, Stabilizer (Rapeseed Co...
Dairy·0 affected·Feb 17, 2012
High RiskFDA
Sunshine Peanut Company
Sunny Boy Low Sodium/ Low Salt Peanut Butter. Product is labeled in part: 35 lb pail labeled in part: ""SunnyBoy LowSodium/LowSalt***...
Dairy·846 affected·Feb 17, 2012
High RiskFDA
Sunshine Peanut Company
Product is 2 oz Peanut Butter. 2 oz pouch labeled in part: "PEANUT BUTTER 2 oz. Pouch***Ingredients: Roaster Peanuts, Sugar, Hydrogenate...
Dairy·406 affected·Feb 17, 2012
High RiskFDA
Sunshine Peanut Company
Sunny Boy NoSalt Peanut Butter. No label was provided by the firm for this product. Product would have been labeled in part: "***Sunn...
Dairy·12 affected·Feb 17, 2012
High RiskFDA
Sunshine Peanut Company
Product is 50 lb Bag Peanut Butter. Product Case is labeled in part: "***50 Lbs Bag***PEANUT BUTTER***PRODUCT OF USA*** 50 Lb B...
Dairy·48 affected·Feb 17, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor...
Medical Devices·10,250 affected·Feb 17, 2012
High RiskFDA
Daaks International
Fenugreek, 3 dozen per case.
Food·388 affected·Feb 13, 2012
High RiskFDA
Ossur Americas, Inc.
The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The prosthesis is composed of t...
Medical Implants·17 affected·Feb 12, 2012
High RiskFDA
Covidien Llc Dba Uni-patch
Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO brand A cutaneous electrode is an electrode that is appli...
Medical Devices·28,138 affected·Feb 9, 2012
High RiskFDA
Integra Lifesciences Corp.
Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plates are intended f...
Medical Devices·2,437 affected·Feb 9, 2012
High RiskFDA
Covidien Llc Dba Uni-patch
Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, A cutaneous electrode is an electrode that is applied direct...
Medical Devices·3,290 affected·Feb 9, 2012
High RiskFDA
Covidien Llc Dba Uni-patch
Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an electrode that i...
Medical Devices·2,014 affected·Feb 9, 2012
High RiskFDA
Physicians Total Care, Inc.
Lipitor (Atorvastatin calcium); 40 mg, 30 TABLETS, Rx only, Repacked & distributed: Physicians Total Care, Inc., Tulsa OK 74146, NDC 5486...
Oral Drugs·3 affected·Feb 8, 2012
High RiskFDA
Afassco Inc
The finger cots are made out of natural rubber. They are disposable products used to cover a fingertip bandage when working with liquids...
Medical Devices·1,956 affected·Feb 8, 2012
High RiskFDA
Sanofi-aventis Us, Inc.
Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0590-10
Injectable Drugs·196,355 affected·Feb 6, 2012
High RiskFDA
Sanofi-aventis Us, Inc.
Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-059...
Injectable Drugs·387,738 affected·Feb 6, 2012
High RiskFDA
Accumetrics Inc
VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots. Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay u...
Diagnostic Devices·26,075 affected·Feb 6, 2012
High RiskFDA
Metrex Research, Llc.
CaviCide, Part Numbers: 13-1025, 13-1000, 13-1024, MC-1000. Alternate brands: EnviroCide, part number: 13-3325. Private labeled...
Surgical Devices·17,690 affected·Feb 6, 2012
High RiskFDA
Accumetrics Inc
VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or poi...
Diagnostic Devices·1,167 affected·Feb 6, 2012
High RiskFDA
Bottling Llc Dba Pepsi Beverages Company
Diet Crush Orange Soda, 12 oz cans
Beverages·1,791 affected·Feb 5, 2012
High RiskFDA
Hospira Inc.
*** 1) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PLUM A+3; for use with Hospira MedNet; *** 2) Plum A+ Infusi...
Medical Devices·1 affected·Feb 5, 2012
High RiskFDA
Hospira Inc.
Plum A+ Infusion Pump; List Number: 12618; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that...
Medical Devices·12,618 affected·Feb 5, 2012
High RiskFDA
Hospira Inc.
Plum A+ Infusion Pump; List Number: 11973; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that...
Medical Devices·11,973 affected·Feb 5, 2012
High RiskFDA
Hospira Inc.
Plum A+3 Infusion Pump System; List Number: 12348; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devi...
Medical Devices·12,348 affected·Feb 5, 2012
High RiskFDA
Orthosensor
"****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.co...
Medical Devices·9 affected·Feb 4, 2012
High RiskFDA
Lloyd Inc
Thyro-Tab 0.050mg., packaged in bulk drums for repackaging. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
Drugs·1,924,297 affected·Feb 3, 2012
High RiskFDA
Lloyd Inc
Levothroid (levothyroxine sodium tablets, USP), 50 mcg., packaged in 100-ct. bottles, RX, NDC 0456-1321-01. Manufactured for Forest Phar...
Oral Drugs·19,166 affected·Feb 3, 2012
High RiskFDA
Abbott Point Of Care Inc.
i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat BNP test is an in vitro diagnostic test for the quantitative measurement ...
Cardiac Devices·1,004,200 affected·Feb 1, 2012
High RiskFDA
Abbott Point Of Care Inc.
i-Stat CK-MP cartridges Abbott Point of Care Inc. The i-Stat CKMB test is an in vitro diagnostic test for the quantitative measuremen...
Diagnostic Devices·368,149 affected·Feb 1, 2012
High RiskFDA
Roche Molecular Systems, Inc.
COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold sample input tubes in the CO...
Medical Devices·2,132 affected·Feb 1, 2012
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Dis...
Medical Devices·532 affected·Jan 26, 2012
High RiskFDA
Exactech, Inc.
REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 3.2mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Ga...
Medical Implants·2 affected·Jan 24, 2012
High RiskFDA
Exactech, Inc.
REF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 3.2mm***Use with 40mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Ga...
Medical Implants·2 affected·Jan 24, 2012
High RiskFDA
Exactech, Inc.
REF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Ga...
Medical Implants·2 affected·Jan 24, 2012
High RiskFDA
Ge Healthcare, Llc
VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139; 45296200; 45296350; 45296477; 45296964; 45297001; 45296966;...
Medical Devices·1,296 affected·Jan 23, 2012
High RiskFDA
Atico International Usa, Inc.
Roundy's Rich Fields Butter Cookies. Product is labeled in part: Side of tin: "***RICH FIELDS*** Butter Cookies***NET WT 12 OZ (340g)...
Dairy·22,068 affected·Jan 20, 2012
High RiskFDA
Nihon Kohden America Inc
MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifi...
Medical Devices·477 affected·Jan 19, 2012
High RiskFDA
Stryker Spine
Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker Spine SAS Z.1 Marticot-33610-Cestas -France +33 (0) 5.57.97.06.30 htt...
Medical Devices·273 affected·Jan 13, 2012
High RiskFDA
Vital Scientific N.v.
Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzer intended for clinical use
Medical Devices·4 affected·Jan 10, 2012
High RiskFDA
The Anspach Effort, Inc.
"***Electric Systems Foot Control****Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium.
Medical Devices·16 affected·Jan 9, 2012
High RiskFDA
Synthes, Inc.
Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
Medical Implants·38 affected·Jan 6, 2012
High RiskFDA
Cook Ireland Ltd.
Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angi...
Medical Implants·15 affected·Jan 5, 2012