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Showing 66981–67000 of 68218 results

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Independence Technology LLC: iBOT 3000 Mobility System. Independence IBOT 3000 Mobili...

iBOT Mobility System may tip over due to malfunction in power base.

FDAJul 1, 2004IN, VA• Independence Technology LLC

Cryolife Inc: CryoValve, Aortic Valve

The sterilization cycle for the instruments used during the procurement of the tissue from the donor had expired.

FDAJul 1, 2004CA, TX• Cryolife Inc

Cryolife Inc: CryoValve, Conduit and Pulmonary Valve

The sterilization cycle for the instruments used during the procurement of the tissue from the donor had expired.

FDAJul 1, 2004CA, TX• Cryolife Inc

Pride Mobility Product Corp: Victory Motorized Vehicle, 3 wheel Model SC1600

intermittent operation

FDAJul 1, 2004Nationwide• Pride Mobility Product Corp

Terumo Cardiovascular Systems Corp: Terumo Perfusion System 9000 Roller Pump; Model 9000; Cat...

Roller Pump: Due to a circuit board malfunction the roller pumps may stop during use without displaying an error message, may stop during use with an overspeed error posted on the local display, or may fail to start/restart resulting in the pump(s) being non-functional.

FDAJul 1, 2004Nationwide• Terumo Cardiovascular Systems Corp

Terumo Cardiovascular Systems Corp: Terumo Perfusion System 8000 Roller Pump, 115V; Model 800...

Roller Pump: Due to a circuit board malfunction the roller pumps may stop during use without displaying an error message, may stop during use with an overspeed error posted on the local display, or may fail to start/restart resulting in the pump(s) being non-functional.

FDAJul 1, 2004Nationwide• Terumo Cardiovascular Systems Corp

Fisher Diagnostic, A Company of Fisher Scientific LLC: Pacific Hemostasis D-Dimer Assay Kit, Fisher Diagnostics ...

Defective reagent may cause in vitro diagnostic test kit to yield false positive test results in clinical samples.

FDAJul 1, 2004Nationwide• Fisher Diagnostic, A Company of Fisher Scientific LLC

Terumo Cardiovascular Systems Corp: Terumo Perfusion System 8000 Roller Pump, 1040V; Model 80...

Due to a circuit board malfunction the roller pumps may stop during use without displaying an error message, may stop during use with an overspeed error posted on the local display, or may fail to start/restart resulting in the pump(s) being non-functional.

FDAJul 1, 2004Nationwide• Terumo Cardiovascular Systems Corp

Pride Mobility Product Corp: Victory Motorized Vehicle 4 wheels Model SC1700

intermittent operation

FDAJul 1, 2004Nationwide• Pride Mobility Product Corp

Nichols Institute Diagnostics: Nichols Advantage 25-Hydroxy Vitamin D Assay, Catalog num...

Lower than expected results are obtained.

FDAJun 30, 2004Nationwide• Nichols Institute Diagnostics

Unknown Manufacturer: HA Hip Stem, cementless

Hip stem product was mis-labeled with wrong size.

FDAJun 30, 2004FL

Diasorin Inc.: DiaSorin 25-HydroxyvitaminD [125I] RIA Kit. For the quan...

An incorrect expiration date of 2005/08/18 was placed on the kit box label for 25-hydroxyvitamin D [125I] RIA kits, Catalog 68100E, Lot 113300B. Correct label expiration date is 2004/08/18.

FDAJun 30, 2004AZ, GA, IL +4 more• Diasorin Inc.

Roche Diagnostics Corp.: ACCU-CHEK Inform meter; catalog No. 3035123.

Exposure to excessive disinfectant or cleaning solution may cause overheating, melting, or smoke.

FDAJun 30, 2004Nationwide• Roche Diagnostics Corp.

Diasorin Inc.: PolyTiter software version 2.8 for use in the Polymedco P...

The program for a specific immunofluorescent titration system (Polymedco PolyTiter immunofluorescent Titration System) was found faulty in that the calibrator 2 value was incorrectly programmed as 1:120 instead of 1:160.

FDAJun 30, 2004AL, AZ, CA +10 more• Diasorin Inc.

Roche Diagnostics Corp.: ACCU-CHEK Inform base unit; catalog no. 3035131.

Exposure to excessive disinfectant or cleaning solution may cause overheating, melting, or smoke.

FDAJun 30, 2004Nationwide• Roche Diagnostics Corp.

Integra LifeSciences Corporation: MAYFIELD Radiolucent Disposable Adult Skull Pins (Sterile...

Skull pins, which fractured below device specifications during QC testing, were distributed.

FDAJun 29, 2004CO, MD, NY +1 more• Integra LifeSciences Corporation

Minxray Inc: MinXray P200R40 Mobile Podiatry X-Ray System, Model PM200...

The x-ray units are defective under 21 CFR 1020.30(h) in that the user manual had missing or inadequate information.

FDAJun 29, 2004AR, CA, FL +6 more• Minxray Inc

Aaron Medical Industries, Inc.: Battery-operated Cautery High Temperature, fine/Loop/ Va...

The cover caps on some of these cauteries are not properly engaged to prevent inadvertent activation.

FDAJun 29, 2004IN• Aaron Medical Industries, Inc.

Aaron Medical Industries, Inc.: Battery-operated Cautery Low Temperature, fine/elongated...

The cover caps on some of these cauteries are not properly engaged to prevent inadvertent activation.

FDAJun 29, 2004IN• Aaron Medical Industries, Inc.

Smiths Medical ASD, Inc.: Portex Hypodermic Needle-Pro Syringe and Needle 1ml/LS Sm...

Sterility of product is not assured

FDAJun 29, 2004Nationwide• Smiths Medical ASD, Inc.

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