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Showing 67421–67440 of 68218 results

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Unknown Manufacturer: Hem-o-LokSMX Legating Clip, REF 544220, Lot 988384, Non-a...

Malformation of the Hem-o-lok SMX clip.

FDAJan 23, 2004AL, CA, FL +11 more

Diasorin Inc.: DiaSorin Anti-Cardiolipin IgA ELISA kit for the detection...

DiaSorin Anti-Cardiolipin IgA kit's positive control is out of acceptable limits.

FDAJan 23, 2004GA, KS, NY• Diasorin Inc.

Moving Solutions, Inc.: Faaborg patient lift/hoist, battery operated lifts. The P...

Excessive wear of the hanger bar bolt, that connects the lift arm to the sling spreader bar, may cause the bolt to snap allowing the patient to fall.

FDAJan 21, 2004Nationwide• Moving Solutions, Inc.

Pioneer Surgical Technology: Stayfuse brand intramedullary bone screw; MID 3.8 x 6 mm....

Product labeled as size 3.8x6 mm implant may actually be size 4.3x6 mm implant.

FDAJan 20, 2004Nationwide• Pioneer Surgical Technology

Coherent, Inc.: Coherent brand DUO Diode Laser Systems. A Non-medical, cl...

Software problem that may cause unintended emission of laser radiation.

FDAJan 19, 2004IN, NC• Coherent, Inc.

DeRoyal Surgical Tray: Multidex Powder, Maltodextrin Wound Dressing, Catalog Num...

Hydrophilic powder wound dressing, sterilized at a dosage which subsequently failed a sterility audit, was distributed.

FDAJan 19, 2004Nationwide• DeRoyal Surgical Tray

Cryolife Inc: CryoValve, Pulmonary Valve & Conduit

Microorganisms were detected in associated tissue.

FDAJan 16, 2004CA, MI, OK• Cryolife Inc

GVI Technology Partners: CDLCAM, First-Pass Radionuclide Angiography Camera System...

Due to limitations in the operating software, the acquired scan may not be processed properly.

FDAJan 16, 2004Nationwide• GVI Technology Partners

Cryolife Inc: Synergraft CryoValve, Aortic Valve & Conduit SG

Microorganisms were detected in associated tissue.

FDAJan 16, 2004CA, MI, OK• Cryolife Inc

Cryolife Inc: CryoValve, Aortic Valve & Conduit

Microorganisms were detected in associated tissue.

FDAJan 16, 2004CA, MI, OK• Cryolife Inc

Depuy Orthopaedics, Inc.: P.F.C. Modular Knee System Modular Plus Tibial Wedge 10...

Screw size included in system was incorrect

FDAJan 15, 2004IA• Depuy Orthopaedics, Inc.

Wilson-Cook Medical Inc: Four Shooter Saeed Multi-Band Ligator

Product label lacks the symbols specifying the meaning of the manufacturing and expiration date.

FDAJan 15, 2004CA, IN• Wilson-Cook Medical Inc

bioMerieux Inc: VITEK GPS-106 Gram Positive Susceptibility Card, Catalog ...

The cards were stamped with an incorrect card code that causes the system to read and analyze the cards incorrectly.

FDAJan 15, 2004Nationwide• bioMerieux Inc

U & I America: 4mm Hex Driver

Reports of hex driver tips breaking off or becoming worn or stripped.

FDAJan 14, 2004MN• U & I America

Lorad, A Division of Hologic: Lorad MIV Platinum Mammograpgy System

System failed to meet the mA's accuracy specfications at low mA's values

FDAJan 14, 2004Nationwide• Lorad, A Division of Hologic

Medtronic, Inc.: Medtronic SiteSeer 5 F Tight Radius 145 Pigtail Cardiov...

Catheter distal tip may separate

FDAJan 14, 2004NC, WA• Medtronic, Inc.

Lorad, A Division of Hologic: Lorad M-IV Mammography System

System failed to meet the mA's accuracy specfications at low mA's values

FDAJan 14, 2004Nationwide• Lorad, A Division of Hologic

U & I America: 2.5mm Hex Driver

Reports of hex driver tips breaking off or becoming worn or stripped.

FDAJan 14, 2004MN• U & I America

Zimmer Dental Inc: Biovent Implant Line

Sterility barrier compromised.

FDAJan 13, 2004Nationwide• Zimmer Dental Inc

Zimmer Dental Inc: Microvent Implant Line

Sterility barrier compromised.

FDAJan 13, 2004Nationwide• Zimmer Dental Inc

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