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High RiskFDA
Spinefrontier, Inc.
lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
Medical Devices·4 affected·Dec 19, 2014
High RiskFDA
Ge Healthcare
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx
Medical Devices·6 affected·Dec 19, 2014
High RiskFDA
Mckesson Israel Ltd.
McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute and manage inf...
Medical Devices·9 affected·Dec 19, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 IntelliVue Info Center iX 86...
Medical Devices·10,013 affected·Dec 19, 2014
High RiskFDA
Sunrise Medical (us) Llc
Quickie Q7 Adult Rigid Wheelchair Model EIR4.
Medical Devices·6 affected·Dec 19, 2014
High RiskFDA
Fresenius Kabi Usa, Llc
HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi...
Medical Devices·69,725 affected·Dec 19, 2014
High RiskFDA
Ge Healthcare
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx
Medical Devices·6 affected·Dec 19, 2014
High RiskFDA
Ge Healthcare
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx
Medical Devices·6 affected·Dec 19, 2014
High RiskFDA
Angiodynamics
Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product No. H7877001039091, Catalog No. 700-103909; 25cm/14Ga/6....
Medical Devices·43 affected·Dec 19, 2014
High RiskFDA
Ge Healthcare
GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.
Medical Devices·13 affected·Dec 19, 2014
High RiskFDA
Vitony Bakery, Inc.
Guava filled pastry ("Pastelillo de Guayaba" in Spanish) 2.5 oz and 10 oz.
Bakery & Grains·204 affected·Dec 18, 2014
High RiskFDA
Tai Foong U.s.a., Inc
The package reads in part "***Northern Chef***GLUTEN FREE, OVEN READY LIGHTLY COATED COD***KEEP FROZEN/DO NOT REFREEZE***NET WT 10 OZ.(28...
Frozen Food·861 affected·Dec 18, 2014
High RiskFDA
Sysmex Corporation
The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use...
Diagnostic Devices·1,137 affected·Dec 18, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
Medical Devices·103 affected·Dec 18, 2014
High RiskFDA
Spinal Elements, Inc
Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This device is intended to be used with autogenous bone graft. Pati...
Medical Devices·1,200 affected·Dec 18, 2014
High RiskFDA
St Jude Medical Cardiac Rhythm Management Division
Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter
Medical Devices·257,456 affected·Dec 18, 2014
High RiskFDA
Ziemer Usa Inc
Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.
Surgical Devices·26 affected·Dec 18, 2014
High RiskFDA
Tovli, Inc.
Vegi-Chef Potato Knishes retail pack 1 lb. 8 oz. (680g), UPC 046676-91114-1
Food·445 affected·Dec 17, 2014
High RiskFDA
Neolpharma, Inc.
Alprazolam tablets, USP, CIV, 0.25 mg, Rx Only, a) 500 count bottle, b) 1000 count bottle, Distributed by: Greenstone LLC, Peapack, NJ, 0...
Injectable Drugs·12,310 affected·Dec 17, 2014
High RiskFDA
Tropichem Research Labs, Inc.
Entertainer's Secret Throat Relief, 2.0 FL oz (59.2 mL), Honey Apple Flavor, KLI Corp, Carmel, IN
Drugs·24,348 affected·Dec 17, 2014
High RiskFDA
Zimmer Gmbh
CoCr Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur i...
Medical Devices·1,908 affected·Dec 17, 2014
High RiskFDA
Zimmer Gmbh
Metasul Femoral Head - indicated for total hip arthroplasty for treatment of patient conditions of non-inflammatory degenerative joint d...
Medical Devices·16 affected·Dec 17, 2014
High RiskFDA
Zimmer Gmbh
Metasul Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femu...
Medical Devices·30 affected·Dec 17, 2014
High RiskFDA
Aesculap, Inc.
Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ...
Medical Devices·772 affected·Dec 17, 2014
High RiskFDA
Stryker Craniomaxillofacial Division
MEDPOR BARRIER Sheets Rectangle Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bear...
Medical Implants·1,051 affected·Dec 17, 2014
High RiskFDA
Stryker Craniomaxillofacial Division
MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for no...
Medical Implants·1,051 affected·Dec 17, 2014
High RiskFDA
Zimmer Gmbh
CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally mature invididuals undergoing primary surgery for re...
Medical Devices·6,109 affected·Dec 17, 2014
High RiskFDA
Zimmer Gmbh
Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in conjunction with compatible acetabular and femoral stem comp...
Medical Devices·10,340 affected·Dec 17, 2014
High RiskFDA
Stryker Craniomaxillofacial Division
MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Numbers A1405048, A1404026 Product Usage: MEDPOR Implan...
Medical Implants·1,051 affected·Dec 17, 2014
High RiskFDA
Jaymac Pharmaceuticals L.l.c.
J-TAN D PD Drops (bromphenirame maleate 1 mg and pseudoephedrine hcl 7.5 mg/ teaspoon), 1 fl oz (30 mL) Bottle, Over the Counter. Manufac...
Drugs·5,572 affected·Dec 16, 2014
High RiskFDA
Arrow International Inc
Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015: Product Usage: Mu...
Surgical Devices·420 affected·Dec 16, 2014
High RiskFDA
Maquet Datascope Corp - Cardiac Assist Division
CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PL...
Medical Devices·838 affected·Dec 16, 2014
High RiskFDA
Leica Microsystems, Inc.
Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining. Product Usage: NCL-L-CD15 is...
Diagnostic Devices·309 affected·Dec 16, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurations: The CentraLink system software ...
Medical Devices·7 affected·Dec 16, 2014
High RiskFDA
Tricar Sales Inc
Organic English Cucumber, 12 pieces per box, PLU 94593, UPC 8 24660 20100 9
Food·3,462 affected·Dec 15, 2014
High RiskFDA
Schwan Food Company Dba Holiday Foods
Hors D'Oeuvre, Holiday Foods¿ Breaded Macaroni and Cheese Bites with Quattro Formaggi Cheese, Lobster & Truffle Oil (item number 4802732)...
Dairy·27 affected·Dec 15, 2014
High RiskFDA
Schwan Food Company Dba Holiday Foods
Hors D'Oeuvre, Holiday Foods¿ Breaded Macaroni & Cheese Bites (item number 4802280). UPC 70220748022808, Keep Frozen, For Institutional U...
Dairy·60 affected·Dec 15, 2014
High RiskFDA
Actavis Elizabeth Llc
Gabapentin Capsules, USP, 300 mg, Rx Only, 100 capsules per bottle, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101,...
Oral Drugs·24,240 affected·Dec 15, 2014
High RiskFDA
Actavis Elizabeth Llc
Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14550-513-02, b) 500 Capsules per bottle, NDC 45963-557-50, Ma...
Oral Drugs·10,857 affected·Dec 15, 2014
High RiskFDA
Actavis Elizabeth Llc
Gabapentin Capsules, USP, 100 mg, Rx Only, a) 100 capsules per bottle, NDC 45963-555-11, b) 500 Capsules per bottle, NDC 45963-555-50, Ma...
Oral Drugs·29,622 affected·Dec 15, 2014
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16
Diagnostic Devices·59,965 affected·Dec 15, 2014
High RiskFDA
Synthes, Inc.
Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of trocar instrumentation. Used i...
Medical Devices·1,762 affected·Dec 15, 2014
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98
Diagnostic Devices·32,159 affected·Dec 15, 2014
High RiskFDA
Nordicneurolab As
nordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used by trained professionals including but not limite...
Diagnostic Devices·16 affected·Dec 15, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. The Ysio Max is a radiographic syst...
Diagnostic Devices·11 affected·Dec 15, 2014
High RiskFDA
Genetic Testing Institute,inc
PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13...
Diagnostic Devices·6,206 affected·Dec 15, 2014
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter, Lactate Assay, Catalog No. OSR6X93
Diagnostic Devices·31,799 affected·Dec 15, 2014
High RiskFDA
American Specialty Pharmacy
Hydroxocobalamin Injection Solution 1 mg/mL Inj., Rx, compounded by American Specialty Pharmacy, Plano, TX 75075 214-919-2090. NDC 99999...
Injectable Drugs·15 affected·Dec 12, 2014