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High RiskFDA
Invacare Corporation
Assist Bed Rail - 6632
Medical Devices·5,020 affected·Apr 25, 2017
High RiskFDA
Bard Access Systems Inc.
StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film ...
Surgical Devices·4,500 affected·Apr 25, 2017
High RiskFDA
Teva Pharmaceuticals Usa
Clozapine Tablets USP, 25 mg, 100-count bottle (NDC 0093-4359-01), 500- count bottle (NDC 0093-4359-05), 100 Unit Dose Blisters per carto...
Oral Drugs·0 affected·Apr 24, 2017
High RiskFDA
Molnlycke Health Care, Inc
Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'
Surgical Devices·956 affected·Apr 24, 2017
High RiskFDA
Beckman Coulter Inc.
Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reagent, when used in conjunction with UniCel DxC 600/800 System(...
Diagnostic Devices·3,158 affected·Apr 24, 2017
High RiskFDA
Orthopediatrics Corp
Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon to apply a reco...
Medical Devices·82 affected·Apr 24, 2017
High RiskFDA
Greatbatch Medical
Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Surgical Inc., # 803-03-159) and EZ Clean" Linear Broach Hand...
Surgical Devices·205 affected·Apr 23, 2017
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt Silicone Flat Drain, 7mm, 3/4 Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are ste...
Surgical Devices·0 affected·Apr 21, 2017
High RiskFDA
Jas Diagnostics Inc.
Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
Diagnostic Devices·14,064 affected·Apr 21, 2017
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt PVC Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile ...
Surgical Devices·0 affected·Apr 21, 2017
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are s...
Surgical Devices·0 affected·Apr 21, 2017
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt Hemaduct Silicone Flat Drain. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile sin...
Surgical Devices·0 affected·Apr 21, 2017
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile sing...
Surgical Devices·0 affected·Apr 21, 2017
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt Silicone Round Drain, 15FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile singl...
Surgical Devices·0 affected·Apr 21, 2017
High RiskFDA
Stryker Communications
Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights used for local illumination of the patients' bod...
Medical Devices·57 affected·Apr 21, 2017
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt Silicone Round Drain, 7FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile singl...
Surgical Devices·0 affected·Apr 21, 2017
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt Hemaduct Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are ste...
Surgical Devices·0 affected·Apr 21, 2017
High RiskFDA
Teleflex Medical
PE CONNECTOR 3/8 Y 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory
Surgical Devices·19,043 affected·Apr 21, 2017
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain,19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage...
Surgical Devices·0 affected·Apr 21, 2017
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage System...
Surgical Devices·0 affected·Apr 21, 2017
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt Hemaduct Silicone Round Drain, 15FR W/15FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage...
Surgical Devices·0 affected·Apr 21, 2017
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt Silicone Round Drain, 10FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile singl...
Surgical Devices·0 affected·Apr 21, 2017
High RiskFDA
Teleflex Medical
PE CONNECTOR 3/8 STRAIGHT 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory
Surgical Devices·19,043 affected·Apr 21, 2017
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/10FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage...
Surgical Devices·0 affected·Apr 21, 2017
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt Hemaduct Silicone Flat Drain, 10mm, Full Ducts W/15FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wo...
Surgical Devices·0 affected·Apr 21, 2017
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt Silicone Flat Drain, 7mm Full W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are ...
Surgical Devices·0 affected·Apr 21, 2017
High RiskFDA
Heb Retail Support Center
Hill Country Fare Wheat Sandwich UPC 4122078985; Good Bread Wheat UPC 4122018146; Clear Bag Wheat; all units 24 oz per bag
Bakery & Grains·409,930 affected·Apr 20, 2017
High RiskFDA
Heb Retail Support Center
HEB Texas Toast UPC 4122062888 and HEB X-Thin UPC 4122084868 all units 24 oz per bag
Food·116,530 affected·Apr 20, 2017
High RiskFDA
Heb Retail Support Center
Hill Country Fare Thin Sandwich UPC 4122046090; Hill Country Fare Extra Thin Sandwich UPC 4122063420; Good Thin Bread; Good Bread Texas T...
Bakery & Grains·1,283,766 affected·Apr 20, 2017
High RiskFDA
Heb Retail Support Center
White Wheat Bread and White Wheat Texas Toast all units 24 oz per bag
Bakery & Grains·246,640 affected·Apr 20, 2017
High RiskFDA
Heb Retail Support Center
HEB White RT UPC 4122035774 and HEB ST White UPC 4122088001 all units 24 oz per bag
Food·388,978 affected·Apr 20, 2017
High RiskFDA
C. O. Truxton
Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distri...
Oral Drugs·0 affected·Apr 20, 2017
High RiskFDA
C. O. Truxton
Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles, Rx Only, Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811, Dist...
Oral Drugs·0 affected·Apr 20, 2017
High RiskFDA
C. O. Truxton
Phenobarbital Tablets USP, 60 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distri...
Oral Drugs·0 affected·Apr 20, 2017
High RiskFDA
C. O. Truxton
Phenobarbital Tablets USP, 100 mg, a) 100 count bottles (NDC 0463-6152-01), b) 1000 count bottles (NDC 0163-6152-10), Rx Only, Manufactur...
Oral Drugs·0 affected·Apr 20, 2017
High RiskFDA
Biomerieux Inc
VITEK¿ 2 Gram Negative Susceptibility card (AST-N351), IVD, REF 421257, 20 cards per carton.
Medical Devices·8,270 affected·Apr 20, 2017
High RiskFDA
Biomerieux Inc
VITEK¿ 2 Gram Positive Susceptibility card (AST-P648), IVD, REF 420857, 20 cards per carton.
Medical Devices·1,852 affected·Apr 20, 2017
High RiskFDA
Biomerieux Inc
VITEK¿ 2 Gram Positive Susceptibility card (AST-P580), REF 22233, 20 cards per carton.
Medical Devices·2,390 affected·Apr 20, 2017
High RiskFDA
Biomerieux Inc
VITEK¿ 2 Gram Negative Susceptibility card (AST-GN80), REF 413437, 20 cards per carton.
Medical Devices·3,131 affected·Apr 20, 2017
High RiskFDA
Biomerieux Inc
VITEK¿ 2 Gram Negative Susceptibility card (AST-N268), REF 413868, 20 cards per carton.
Medical Devices·977 affected·Apr 20, 2017
High RiskFDA
Biomerieux Inc
VITEK¿ 2 Gram Negative Susceptibility card (AST-N300), IVD, REF 416241, 20 cards per carton.
Medical Devices·493 affected·Apr 20, 2017
High RiskFDA
Biomerieux Inc
VITEK¿ 2 Gram Positive Susceptibility card (AST-P607), REF 22335, 20 cards per carton.
Medical Devices·1,182 affected·Apr 20, 2017
High RiskFDA
Biomerieux Inc
VITEK¿ 2 Gram Negative Susceptibility card (AST-N222), REF 413083, 20 cards per carton.
Medical Devices·2,554 affected·Apr 20, 2017
High RiskFDA
Biomerieux Inc
VITEK¿ 2 Gram Negative Susceptibility card (AST-N214), REF 413064, 20 cards per carton.
Medical Devices·3,382 affected·Apr 20, 2017
High RiskFDA
Biomerieux Inc
VITEK¿ 2 Gram Negative Susceptibility card (AST-N362), IVD, REF 421585, 20 cards per carton.
Medical Devices·500 affected·Apr 20, 2017
High RiskFDA
Biomerieux Inc
VITEK¿ 2 Gram Negative Susceptibility card (AST-N265), REF 413865, 20 cards per carton.
Medical Devices·2,476 affected·Apr 20, 2017
High RiskFDA
Biomerieux Inc
VITEK¿ 2 Gram Streptococcus Susceptibility card (AST-ST01), REF 410028, 20 cards per carton.
Medical Devices·19,398 affected·Apr 20, 2017
High RiskFDA
Biomerieux Inc
VITEK¿ 2 Gram Positive Susceptibility card (AST-P631), REF 414961, 20 cards per carton.
Medical Devices·6,320 affected·Apr 20, 2017