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High RiskFDA
West-ward Pharmaceutical Corp.
VERSAPHARM Ethambutol Tablets, USP,400 mg, Rx Only a)60 tablets, NDC 61748-014-06, b)90 tablets, NDC 61748-014-09, c)100 tablets, ND...
Oral Drugs·18,825 affected·Nov 30, 2012
High RiskFDA
West-ward Pharmaceutical Corp.
Lisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1264-01) and b) 1000-count...
Oral Drugs·43,478 affected·Nov 30, 2012
High RiskFDA
St. Jude Medical
Eon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 3711 (Portable Charger) and Eon Mini -3721 (Charger); This is ...
Medical Devices·75,663 affected·Nov 30, 2012
High RiskFDA
Biomet Spine, Llc
Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commerci...
Medical Implants·1,999 affected·Nov 30, 2012
High RiskFDA
Mariposa Labs, Llc
NorthStar Arthritis Relief Cream. Net Wt. 2 oz tube, OTC, Manufactured for and Distributed by NewMarket Health Products, LLC. 702 Cathe...
Topical Drugs·14,664 affected·Nov 29, 2012
High RiskFDA
Thermo Fisher Scientific (asheville) Llc
CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308, 3310, 3311, 3540, 3541, 3542, 3543, 3584, 3585,...
Medical Devices·15,567 affected·Nov 29, 2012
High RiskFDA
Williams West & Witt's Products Company
#326 RS PrimarqueLobster Base, Net Weight 50 Pounds;, PackedFor Primarque Products, Worcester, MA 01610
Seafood·3,000 affected·Nov 28, 2012
High RiskFDA
Williams West & Witt's Products Company
#222-C, Primarque Clam Base, Net Weight 5 pounds (2.27kg) & 16 oz ( 1 LB) 454G Packed for Primarque Products, Worcester, MA 01610 #22...
Food·759 affected·Nov 28, 2012
High RiskFDA
Williams West & Witt's Products Company
#828 Cook's Delight Shrimp Base, Net Weight 30 Pounds; 5 Pounds, Packed by Integrative Flavors, Michigan City, Indian
Seafood·227 affected·Nov 28, 2012
High RiskFDA
Williams West & Witt's Products Company
#126 Primarque Seafood Base, Net Weight 16 oz, 1LB, 454 G & 50 Pounds (22.68 kg) Packed for Primarque Products, Worcester, MA 01610 #12...
Seafood·100 affected·Nov 28, 2012
High RiskFDA
Williams West & Witt's Products Company
#272N Cook's Delight Mushroom Base, Net Weight 50 Pounds (22.68 kg) Packed by Integrative Flavors, Michigan City, Indiana 46360
Food·1,150 affected·Nov 28, 2012
High RiskFDA
Williams West & Witt's Products Company
#425N Primarque Fish Base, Net Weight 50 Pounds (22.68 kg) Packed for Primarque Products, Worcester, MA 01610
Seafood·250 affected·Nov 28, 2012
High RiskFDA
Williams West & Witt's Products Company
#223-E Primarque Clam Base, Net Weight 50 pounds (22.68 kg) Packed for Primarque Products, Worcester, MA 01610
Food·6,450 affected·Nov 28, 2012
High RiskFDA
Williams West & Witt's Products Company
#122-A, Piazza Produce Clam Base, Net Weight 16 oz (1 lb) 454G Packed For: Piazza Produce, Indianapolis, IN 46268: #122-A, Primarqu...
Produce·1,088 affected·Nov 28, 2012
High RiskFDA
Williams West & Witt's Products Company
#321N Primarque Crab Base, Net Weight 50 Pounds, Packed For Primarque Products, Worcester, MA 01610 #321 N Cook's Delight,Crab Base, Net...
Seafood·1,950 affected·Nov 28, 2012
High RiskFDA
Williams West & Witt's Products Company
#822- M PrimarqueClam Base, Net Weight 50 Pounds (22.68 kg) Packed for Primarque Products, Worcester, MA 01610
Food·850 affected·Nov 28, 2012
High RiskFDA
Williams West & Witt's Products Company
#226 Cook's Delight Lobster Base, Net Weight 30 Pounds; 5 Pounds, Packed by Integrative Flavors, Michigan City, Indian
Seafood·516 affected·Nov 28, 2012
High RiskFDA
Williams West & Witt's Products Company
#124-M Primarque Lobster Base, Net Weight (1LB) 454 G & 50 Pounds (22.68 kg) Packed for Primarque Products, Worcester, MA 01610 #124-M ...
Seafood·2,265 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF 98-0033***Custom Autolube Food Guard***Rx Only*** This device is intended to be used with Anspach Systems
Medical Devices·1 affected·Nov 28, 2012
High RiskFDA
Mindray Ds Usa, Inc. D.b.a. Mindray North America
BS-200 Chemistry Analyzer Designed for clinical laboratory use.
Medical Devices·3 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***MA Attachment, Straight version Custom***Rx Only*** This device is intended to be used with Anspach Systems
Medical Devices·6 affected·Nov 28, 2012
High RiskFDA
The Binding Site Group, Ltd.
Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related d...
Medical Devices·1,002 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF 98-0016***eMax 2 Modified Hand Control***Rx Only*** This device is intended to be used with Anspach Systems
Medical Devices·6 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***Custom QD11 Attachment with thinner nose tube***Rx Only*** This device is intended to be used with Anspach Systems
Medical Devices·3 affected·Nov 28, 2012
High RiskFDA
Mindray Ds Usa, Inc. D.b.a. Mindray North America
Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central...
Medical Devices·51 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF 98-0023***Custom 5 cm Extension Bearing Sleeve***Rx Only*** This device is intended to be used with Anspach Systems
Medical Devices·2 affected·Nov 28, 2012
High RiskFDA
Philips Healthcare Inc.
Mobile Diagnostic X-Ray System with Digital Panel
Diagnostic Devices·220 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***Modified QD11 Attachment with Soft Tissue Protector***Rx Only*** This device is intended to be used with Anspach Systems
Medical Devices·6 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF SP-4604-00***3mm Fluted Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Ans...
Medical Devices·19 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF SP-3012-00***13 mm Drill with Depth Stop for Short Heavy Duty Attachment***Rx Only*** This device is intended to be used...
Medical Devices·5 affected·Nov 28, 2012
High RiskFDA
Roche Molecular Systems, Inc.
COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.
Diagnostic Devices·335 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF 98-0022***8 mm Coarse Headless Screw with Driver***Rx Only*** This device is intended to be used with Anspach Systems
Medical Devices·2 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF 98-0042***XMax Motor with Custom Hose***Rx Only*** This device is intended to be used with Anspach Systems
Medical Devices·3 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF SP-5000-00***Threaders, Arthroscopic Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems
Medical Devices·30 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF 98-0035***Custom eMax 2 Plus Motor with microMax Disconnect Sleeve***Rx Only*** This device is intended to be used with ...
Medical Devices·9 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF SP-4601-00***1mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used ...
Medical Devices·10 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF SP-4605-00***Arthroscopic Suture Anchor assembly with Suture Threader***Rx Only*** This device is intended to be used wi...
Medical Devices·68 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF 98-0020***Modified Arthroscopic Knotless Suture Anchor Deployment Tool with Suture Puller***Rx Only*** This device is in...
Medical Devices·1 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***Arthroscopic Knotless Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems
Medical Devices·100 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF 98-0048***Custom Circular ePLUS-FP***Rx Only*** This device is intended to be used with Anspach Systems
Medical Devices·1 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF 98-0019***Modified MDA Tube with MA-D20 Attachment***Rx Only*** This device is intended to be used with Anspach Systems
Medical Devices·1 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF 98-0034***Custom XMax Motor, Pneumatic with Hand Control and Custom Autolube III IRR Foot Pedal***Rx Only*** This device...
Medical Devices·16 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF SP-3014-00***4mm Fluted Ball for MRI***Rx Only*** This device is intended to be used with Anspach Systems
Medical Devices·130 affected·Nov 28, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
Pinnacle Cancellous Screw Packaging: Product is housed within a polyurethane protector; this is placed inside an uncoated Tyvek/PET pe...
Medical Implants·118 affected·Nov 28, 2012
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, an...
Diabetes Devices·28 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***eMax2 Lower Profile Foot Pedal***Rx Only*** This device is intended to be used with Anspach Systems
Medical Devices·21 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF SP-3101-00***Adjustable 25 Cm Mia Attachment, Custom***Rx Only*** This device is intended to be used with Anspach Systems
Medical Devices·1 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***Custom MCA5-1SD with Extended Exposure***Rx Only*** This device is intended to be used with Anspach Systems
Medical Devices·20 affected·Nov 28, 2012