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High RiskFDA
Biomerieux Inc
bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine the susceptibili...
Medical Devices·4 affected·Feb 6, 2013
High RiskFDA
Hospira Inc.
Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20792. The Plum A+ Infusion Systems are a multi-purpose family of device...
Medical Devices·357,778 affected·Feb 6, 2013
High RiskFDA
Hospira Inc.
Plum A+3 Infusion Pump with Hospira MedNet Software. List Number 20678. The Plum A+ Infusion Systems are a multi-purpose family of devic...
Medical Devices·357,778 affected·Feb 6, 2013
High RiskFDA
Hospira Inc.
Plum A+3 Infusion Pump. List Number 12391. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise deli...
Medical Devices·357,778 affected·Feb 6, 2013
High RiskFDA
Hospira Inc.
Plum A+ Infusion Pump. List Number 11973. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise deliv...
Medical Devices·357,778 affected·Feb 6, 2013
High RiskFDA
Zimmer Biomet, Inc.
ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operat...
Surgical Devices·53 affected·Feb 5, 2013
High RiskFDA
Cordis Corporation
Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
Surgical Devices·80 affected·Feb 5, 2013
High RiskFDA
Biomet, Inc.
REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument
Surgical Devices·58 affected·Feb 5, 2013
High RiskFDA
Depuy Orthopaedics, Inc.
Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP Instruments Classic Surgical Technique,0612-89-510 Sigma...
Surgical Devices·4,000 affected·Feb 5, 2013
High RiskFDA
Vital Images, Inc.
Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and ...
Diagnostic Devices·7,649 affected·Feb 5, 2013
High RiskFDA
Aptalis Pharma Us Inc
SourceCF(R) Pediatric Drops, Multivitamins with A, B, D, E and K Plus Zinc, 2 FL OZ. (60ML), NDC 66212-300-60, UPC 668212300600
Supplements·14,439 affected·Feb 4, 2013
High RiskFDA
Carib Import & Export, Inc.
Benjamins Infants Gripe Mixture, Each 5 mL contains: Light Magnesium Carbonate BP, 200.0 mg; Sodium Bicarbonate BP, 100.0 mg; Sucrose, 48...
Drugs·480 affected·Feb 4, 2013
High RiskFDA
Endogastric Solutions Inc
EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01. Label reads in part "EsophyX2 2-L...
Medical Devices·190 affected·Feb 4, 2013
High RiskFDA
Spinenet
SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspirate bone morrow.
Medical Devices·100 affected·Feb 4, 2013
High RiskFDA
Arrow International Inc
The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Acces...
Surgical Devices·2,480 affected·Feb 4, 2013
High RiskFDA
Hospira Inc.
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump ...
Medical Devices·20,311 affected·Feb 4, 2013
High RiskFDA
Hospira Inc.
The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood an...
Medical Devices·2,791 affected·Feb 4, 2013
High RiskFDA
Hospira Inc.
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump ...
Medical Devices·35,596 affected·Feb 4, 2013
High RiskFDA
Icu
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general...
Medical Devices·363,892 affected·Feb 1, 2013
High RiskFDA
Icu
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general...
Medical Devices·21,703 affected·Feb 1, 2013
High RiskFDA
Hospira Inc.
The Plum A+ Hyperbaric Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and ca...
Medical Devices·179 affected·Feb 1, 2013
High RiskFDA
Hospira Inc.
The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used ...
Medical Devices·21,551 affected·Feb 1, 2013
High RiskFDA
Icu
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general...
Medical Devices·10,609 affected·Feb 1, 2013
High RiskFDA
Hospira Inc.
The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used ...
Medical Devices·7,692 affected·Feb 1, 2013
High RiskFDA
Hospira Inc.
The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used f...
Medical Devices·1 affected·Feb 1, 2013
High RiskFDA
Greiner Bio-one North America, Inc.
VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood...
Medical Devices·192,000 affected·Feb 1, 2013
High RiskFDA
Icu
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general...
Medical Devices·184,399 affected·Feb 1, 2013
High RiskFDA
Hospira Inc.
The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used ...
Medical Devices·214 affected·Feb 1, 2013
High RiskFDA
Icu
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general...
Medical Devices·7,848 affected·Feb 1, 2013
High RiskFDA
Icu
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general...
Medical Devices·7,351 affected·Feb 1, 2013
High RiskFDA
Integra Lifesciences Corp.
Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indi...
Medical Devices·154 affected·Feb 1, 2013
High RiskFDA
L. K. Bowman, Incorporated
Canned mushrooms, #10 cans (Brites, not labeled)
Food·3,480 affected·Jan 31, 2013
High RiskFDA
Noven Pharmaceuticals, Inc.
Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch, packaged in 30-count pat...
Topical Drugs·335,910 affected·Jan 31, 2013
High RiskFDA
Salyer Prn Biomedical
Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in car...
Surgical Devices·9 affected·Jan 31, 2013
High RiskFDA
Medtronic Navigation, Inc.
Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile
Medical Devices·463 affected·Jan 31, 2013
High RiskFDA
Hitachi Medical Systems America Inc
Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. The Echelon, Echelon Oval and Oasis MR systems are imagi...
Medical Devices·45 affected·Jan 31, 2013
High RiskFDA
R-kane Products Inc.
Z Pro 25 High Protein Supplement Net. Wt. 1.3 oz. - Vanilla Flavor Formulated and Distributed by: R-Kane Products, Inc. 8351 Natio...
Baby Food & Formula·0 affected·Jan 30, 2013
High RiskFDA
R-kane Products Inc.
Z Pro 25 High Protein Supplement Net. Wt. 1.5 oz. - Chocolate Flavor Formulated and Distributed by: R-Kane Products, Inc. 8351 Na...
Snacks & Candy·0 affected·Jan 30, 2013
High RiskFDA
Tumalo Farms Llc
A soft brie-style cheese called Jewell. Ingredients: Certified organic cows' milk, Pasteurized farmstead goats' milk, cultures, rennet ...
Dairy·222 affected·Jan 30, 2013
High RiskFDA
Tumalo Farms Llc
A soft chevre-style cheese. Label reads in part, "*** TUMALO FARMS Artisan Cheeses of Central Oregon Chevita This fresh and mild, soft, ...
Dairy·1 affected·Jan 30, 2013
High RiskFDA
Tg United, Inc.
AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceutica...
Inhaled / Nasal Drugs·355 affected·Jan 30, 2013
High RiskFDA
Tg United, Inc.
CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayrevil...
Drugs·26,315 affected·Jan 30, 2013
High RiskFDA
Tg United, Inc.
Cardec DM Drops, Decongestant, Antihistamine, Antitussive, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX...
Drugs·216,838 affected·Jan 30, 2013
High RiskFDA
Tg United, Inc.
Poly Hist Forte, Nasal Decongestant, Antihistamine, 100 count bottle, OTC, Manufactured for: Poly Pharmaceuticals, Quitman, MS 39355 NDC...
Inhaled / Nasal Drugs·330,158 affected·Jan 30, 2013
High RiskFDA
Tg United, Inc.
Mesehist DM, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,0887...
Drugs·12,120 affected·Jan 30, 2013
High RiskFDA
Tg United, Inc.
BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: ...
Drugs·22,721 affected·Jan 30, 2013
High RiskFDA
Tg United, Inc.
BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, ...
Drugs·16,836 affected·Jan 30, 2013
High RiskFDA
Tg United, Inc.
AMBI 25CPD/200GFN, Antitussive, Expectorant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Broo...
Drugs·348 affected·Jan 30, 2013