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High RiskFDA
Aesculap, Inc.
ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body replacement or intervertebral body fusion to a...
Medical Implants·9 affected·Jun 18, 2013
High RiskFDA
Physicians Total Care, Inc.
Belladonna Alkaloids/PB (Belladonna Alkaloids / Phenobarbital) Tablets Phenobarbital USP 16.2 mg, Hyoscyamine Sulfate 0.1037 mg, Atropi...
Oral Drugs·270 affected·Jun 17, 2013
High RiskFDA
Nanosphere, Inc.
Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges; are qualitative multiplexed in vitro diagnostic tes...
Diagnostic Devices·20 affected·Jun 17, 2013
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
The SurgiCounter Charging Cradle Product Usage: SurgiCounter Charging Cradles are designed to be used with the SurgiCounter and ar...
Surgical Devices·3,625 affected·Jun 16, 2013
High RiskFDA
Biomerieux Inc
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ES. Part number: 4...
Diagnostic Devices·12,384 affected·Jun 14, 2013
High RiskFDA
Biomerieux Inc
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML2. Part number: 4...
Diagnostic Devices·12,384 affected·Jun 14, 2013
High RiskFDA
Biomerieux Inc
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ZH. Part number: 4...
Diagnostic Devices·12,384 affected·Jun 14, 2013
High RiskFDA
Pioneer Surgical Technology, Inc.
Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System is intended for...
Medical Devices·9 affected·Jun 14, 2013
High RiskFDA
Biomerieux Inc
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML1. Part number: 4...
Diagnostic Devices·12,384 affected·Jun 14, 2013
High RiskFDA
Biomerieux Inc
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 IT. Part number: 4...
Diagnostic Devices·12,384 affected·Jun 14, 2013
High RiskFDA
Biomerieux Inc
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 FR. Part number: 4...
Diagnostic Devices·12,384 affected·Jun 14, 2013
High RiskFDA
Biomerieux Inc
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 PT. Part number: 4...
Diagnostic Devices·12,384 affected·Jun 14, 2013
High RiskFDA
Biomerieux Inc
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 JA. Part number: 4...
Diagnostic Devices·12,384 affected·Jun 14, 2013
High RiskFDA
Biomerieux Inc
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit V2S RP5800XPE TO 6.01 WES7. Part ...
Diagnostic Devices·12,384 affected·Jun 14, 2013
High RiskFDA
El Campestre
El Campestre Brand Ceviche De Camaron. Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton. Labeling ...
Food·0 affected·Jun 13, 2013
High RiskFDA
El Campestre
El Campestre Brand Camaron Aquachile. Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton. Labeling rea...
Food·37 affected·Jun 13, 2013
High RiskFDA
Carefusion 213, Llc
ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Onl...
Drugs·23,000 affected·Jun 13, 2013
High RiskFDA
Church & Dwight Inc
Arm & Hammer Baking Soda a) Net Wt. 1 LB. (454 g) UPC 3320001130 b) Net Wt. 8 oz. (277 g) UPC 3320001110 Church & Dwight, Co. Inc. 46...
Beverages·8 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products PROT Slides packaged as 90 slides/pack catalog number 8208431 VITROS PROT Slides quantitatively measure protei...
Medical Devices·19,438 affected·Jun 12, 2013
High RiskFDA
Accelerated Care Plus Corporation
Omnicycle Elite; US Importer and Distributor: Accelerated Care Plus, Reno NV. Manufactured by Medica Medizintechnik GmbH, Hochdorf, Germa...
Medical Devices·1,001 affected·Jun 12, 2013
High RiskFDA
Physio Control, Inc.
The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This softw...
Cardiac Devices·139 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products SALI Slides packaged as 90 slides/pack catalog number 1314343 VITROS SALI Slides quantitatively measure salicy...
Medical Devices·15,492 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products ALKP Slides, 300 slides/pack; catalog number 1053180 VITROS ALKP Slides quantitatively measure alkaline phosph...
Medical Devices·183,267 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products PHOS Slides packaged as 300 slides/pack catalog number 1513209 VITROS PHOS Slides quantitatively measure phosp...
Medical Devices·81,382 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog number 1202670 and packaged as 90 slides/pack catalog number 81...
Medical Devices·70,125 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products ALB Slides, 90 slides/pack; catalog number 1988211 VITROS ALB Slides quantitatively measure (ALB) concentratio...
Medical Devices·16,583 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Li Slides packaged as 300 slides/pack catalog number 8318925 and packaged as 90 slides/pack catalog number 1632...
Medical Devices·62,039 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Mg Slides packaged as 300 slides/pack catalog number 8255093 and packaged as 90 slides/pack catalog number 1921...
Medical Devices·101,976 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products DGXN Slides packaged as 90 slides/pack catalog number 8343386 VITROS DGXN Slides quantitatively measure digoxi...
Medical Devices·24,857 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products TBIL Slides packaged as 300 slides/pack catalog number 8159931 VITROS TBIL Slides quantitatively measure total...
Medical Devices·175,689 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products CHE Slides packaged as 300 slides/pack catalog number 1914605 and packaged as 90 slides/pack catalog number 800...
Medical Devices·11,135 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products LIPA Slides packaged as 300 slides/pack catalog number 1668409 and packaged as 90 slides/pack catalog number 82...
Medical Devices·62,039 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products BuBc Slides packaged as 300 slides/pack catalog number 8383051 and packaged as 90 slides/pack catalog number 16...
Medical Devices·74,792 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Ca Slides packaged as 300 slides/pack catalog number 1450261 VITROS Ca Slides quantitatively measure calcium (...
Medical Devices·231,112 affected·Jun 12, 2013
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224, 6F Product Usa...
Surgical Devices·15 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products ECO2 Slides packaged as 300 slides/pack catalog number 8262396 VITROS ECO2 Slides quantitatively measure total...
Medical Devices·205,534 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products UPRO Slides packaged as 90 slides/pack catalog number 6800120 VITROS UPRO Slides quantitatively measure protei...
Medical Devices·31,395 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products URIC Slides packaged as 300 slides/pack catalog number 1943927 VITROS URIC Slides quantitatively measure uric ...
Medical Devices·85,646 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products THEO Slides packaged as 300 slides/pack catalog number 8301764 and packaged as 90 slides/pack catalog number 13...
Medical Devices·7,926 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products CREA Slides packaged as 300 slides/pack catalog number 6802584 VITROS CREA Slides quantitatively measure creat...
Medical Devices·364,752 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Fe Slides packaged as 300 slides/pack catalog number 1515808 and packaged as 90 slides/pack catalog number 1924...
Medical Devices·37,525 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products CRP Slides packaged as 90 slides/pack catalog number 8097990 VITROS CRP Slides quantitatively measure C-reacti...
Medical Devices·86,522 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products CK-MB Slides packaged as 300 slides/pack catalog number 8058232 and packaged as 90 slides/pack catalog number 8...
Medical Devices·28,739 affected·Jun 12, 2013
High RiskFDA
Church & Dwight Inc
Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, Sodium Bicarbonate U.S.P. No. 4 Granular, Net Wt. 50 lbs. (22.68 kg.) per bag, Man...
Drugs·749 affected·Jun 11, 2013
High RiskFDA
Church & Dwight Inc
Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP1 Grade, packaged in bags of various quantities, Church & Dwight ...
Drugs·749 affected·Jun 11, 2013
High RiskFDA
Church & Dwight Inc
Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP5 Grade, packaged in bags of various quantities, Church & Dwight ...
Drugs·749 affected·Jun 11, 2013
High RiskFDA
Church & Dwight Inc
Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP3 Grade, packaged in bags of various quantities, Church & Dwight ...
Drugs·749 affected·Jun 11, 2013
High RiskFDA
Church & Dwight Inc
Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP2 Grade, packaged in bags of various quantities, Church & Dwight ...
Drugs·749 affected·Jun 11, 2013