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Showing 62441–62460 of 68218 results

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Bausch & Lomb Inc: Bausch & Lomb Millennium Phacoemulsification Needles, Nee...

The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable

FDAMar 26, 2008Nationwide• Bausch & Lomb Inc

CryoLife, Inc.: CryoValve, Aortic Valve & Conduit

Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed.

FDAMar 26, 2008DE, IN, TN• CryoLife, Inc.

Zimmer Inc.: Zimmer Spine Cyclone anterior cervical plate, 1 Level, 14...

The screw locking cap may fracture when the surgeon rotates it into the locked position.

FDAMar 26, 2008AZ, CA, FL +14 more• Zimmer Inc.

Bausch & Lomb Inc: Bausch & Lomb Millenium Phacoemulsification Needles, Need...

The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable

FDAMar 26, 2008Nationwide• Bausch & Lomb Inc

CryoLife, Inc.: CryoValve, Pulmonary Valve & Conduit

Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed.

FDAMar 26, 2008DE, IN, TN• CryoLife, Inc.

Medtronic Heart Valve Division: Hall Easy-Fit Prosthetic Heart Valve - Aortic A7700. Th...

Medtronic has identified an issue with 685 Hall Easy-Fit valves Models A7700 and M7700 in which the holder of the valve was incorrectly secured to the valve. This could potentially make it difficult to easily disengage the holder from the valve.

FDAMar 25, 2008AR, CA, IL +11 more• Medtronic Heart Valve Division

Biosense Webster Inc: Circular Mapping Catheter-Biosense Webster LASSO 2515 Var...

This recall was initiated after the firm received several complaints reporting issues with deflection. The catheter may become caught in the mitral valve, requiring surgical procedures, valve may be torn while trying to dislodge, unable to retract the catheter through the sheath and require surgical intervention to remove, pulling on catheter to remove may lead to large atrial septal tear, and sep

FDAMar 25, 2008Nationwide• Biosense Webster Inc

Abbott Spine: InCompass Spinal Fixation System T-Handle Driver; Part #2...

Reports received regarding disassembly of T-Handle Driver components during surgery dropping the closure top into the surgical site.

FDAMar 24, 2008Nationwide• Abbott Spine

Abbott Spine: PathFinder Spinal Fixation System T-Handle Driver; Part 2...

Reports received regarding disassembly of T-Handle Driver components during surgery dropping the closure top into the surgical site.

FDAMar 24, 2008Nationwide• Abbott Spine

Siemens Healthcare Diagnostics Inc.: Dimension Total Prostate Specific Antigen (TPSA) Flex Rea...

False Results: The product may exhibit falsely elevated results. The affected lots demonstrate sporadic variability in recovery of calibrator and quality control; therefore this issue may not be readily detected upon calibration or during routine processing of Quality Control.

FDAMar 24, 2008Nationwide• Siemens Healthcare Diagnostics Inc.

Smiths Medical Asd Inc: Medex MX821L 72 inch (182.9cm) Administration Sets, Stand...

Misbranded/mispackaged device was distributed. Product labeled to contain 72 inch Standard Drip ( IV) Administration Sets, actually contained 60 inch (IV) administration sets with a' Y' site.

FDAMar 24, 2008IL, MN, NJ +2 more• Smiths Medical Asd Inc

Integra LifeSciences Corp.: PANTA Nails, 10mm x 150 length, Newdeal, Lyon France; Int...

Certain PANTA Nails from one lot were incorrectly manufactured. The internal thread for certain PANTA Nails (Part Number 500050ND; Lot Number: E7XX) may present an insufficient depth and may not allow the engagement of the threaded part of the compression device. The risks presented include: an increase in surgery time, or the implantation of a nail less ideally suited for the patient's anatomy

FDAMar 24, 2008Nationwide• Integra LifeSciences Corp.

Philips Medical Systems North America Co. Phillips: Philips OmniDiagnost Eleva X-Ray System is a diagnostic i...

Unexpected movement of the X-ray table may occur. These movements may lead to patient injury, e.g., an uncontrolled tilt may cause the patient to slip off.

FDAMar 22, 2008Nationwide• Philips Medical Systems North America Co. Phillips

Diamedix Corporation: Is-anti-Gliadin IgG Enzyme Immunoassay Test Kit packaged ...

Standards and controls in the Is-anti-Gliadin IgG Test Kits are exhibiting low activity. A drop in the O.D.s the Positive Control could potentially recover low out of range (which would invalidate the test), or false positive test results could be obtained.

FDAMar 21, 2008Nationwide• Diamedix Corporation

Siemens Medical Solutions USA, Inc.: Sonoline Antares 5.0 ultrasound system at SW revision 200...

Software issue may result in distorted images and inaccurate measurements, which could lead to a misdiagnosis.

FDAMar 21, 2008AZ, CA, FL +33 more• Siemens Medical Solutions USA, Inc.

Roche Diagnostics Corp.: Roche/Hitachi Modular Analytics System, Modular D2400 Mod...

Possible mismatch between patient and result.

FDAMar 21, 2008Nationwide• Roche Diagnostics Corp.

Covidien Limited: Puritan-Bennett 800 Series Ventilator Backup Power Source...

Wiring in battery back-up power supply may short and cause thermal damage to ventilator.

FDAMar 21, 2008Nationwide• Covidien Limited

Siemens Medical Solutions USA, Inc.: ACUSON Antares 5.0 ultrasound system at SW revision 200.0...

Software issue may result in distorted images and inaccurate measurements, which could lead to a misdiagnosis.

FDAMar 21, 2008AZ, CA, FL +33 more• Siemens Medical Solutions USA, Inc.

Medefil Incorporated: Medifil Heparin I.V. Flush Syringe 100 units/mL; a polypr...

The heparin lock flush solution was manufactured from contaminated Heparin Sodium USP Active Pharmaceutical Ingredient (API). The FDA has received reports of serious injuries and/or deaths in patients administered finished heparin injectable products manufactured from heparin API containing this contaminant.

FDAMar 20, 2008Nationwide• Medefil Incorporated

Medefil Incorporated: Medefil Heparin I.V. Flush Syringe 10 units/mL; a polypro...

The heparin lock flush solution was manufactured from contaminated Heparin Sodium USP Active Pharmaceutical Ingredient (API). The FDA has received reports of serious injuries and/or deaths in patients administered finished heparin injectable products manufactured from heparin API containing this contaminant.

FDAMar 20, 2008Nationwide• Medefil Incorporated

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