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Showing 18581–18600 of 22584 results

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Advanced Medical Optics, Inc.: AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses

The lenses are incorrectly labeled as 11 diopter lenses; these lenses are actually 22.5 diopters.

FDANov 29, 2006CT, NY, TX• Advanced Medical Optics, Inc.

Stryker Howmedica Osteonics Corp.: Howmedica Hip Fracture Stem System, Product Number: 6942-...

Lack of assurance of Sterility (package integrity): Anomalies in seal width and strength that may affect the integrity of the sterile barrier.

FDANov 28, 2006Nationwide• Stryker Howmedica Osteonics Corp.

Edwards Lifesciences Technology SARL: Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infu...

Misbranding-One lot of Swan-Ganz Thermodilution VIP Catheters, Model 831HF75, lot 246HC197 was labeled with different model information (831F75) on the edge label . The edge label states the model is 831F75 which incorrectly indicates that product does NOT contain an antimicrobial heparin coating. (The tray lid label correctly states the model is 831HF75, containing the heparin coating)

FDANov 27, 2006Nationwide• Edwards Lifesciences Technology SARL

Baxter Healthcare Corp. Rt.: Baxter Flo-Gard 6201 Volumetric Infusion Pump, catalog #2...

There is the potential for non-detection of, and no alarm for, upstream occlusion for Flo-Gard Volumetric Infusion Pumps, if an occlusion occurs above a flexible chamber such as a drip chamber, Buretrol or blood filter.

FDANov 27, 2006PR• Baxter Healthcare Corp. Rt.

Plus Orthopedics USA: VKS Tibial Trial, Right/Left, Prep Guide; Model Number: ...

The VKS "Tibial Trial" was found to have an incorrect fixation pin hole diameter.

FDANov 27, 2006Nationwide• Plus Orthopedics USA

Baxter Healthcare Corp. Rt.: Baxter Flo-Gard 6300 Dual Channel Volumetric Infusion Pum...

There is the potential for non-detection of, and no alarm for, upstream occlusion for Flo-Gard Volumetric Infusion Pumps, if an occlusion occurs above a flexible chamber such as a drip chamber, Buretrol or blood filter.

FDANov 27, 2006PR• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pum...

There is the potential for non-detection of, and no alarm for, upstream occlusion for Flo-Gard Volumetric Infusion Pumps, if an occlusion occurs above a flexible chamber such as a drip chamber, Buretrol or blood filter.

FDANov 27, 2006PR• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: Baxter Flo-Gard 6200 Volumetric Infusion Pump, catalog #2...

There is the potential for non-detection of, and no alarm for, upstream occlusion for Flo-Gard Volumetric Infusion Pumps, if an occlusion occurs above a flexible chamber such as a drip chamber, Buretrol or blood filter.

FDANov 27, 2006PR• Baxter Healthcare Corp. Rt.

Fisher & Paykel Healthcare Inc: Fisher & Paykel Spares CPAP Mask and Connectors, Part Num...

Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and there is an extremely remote possibility that the broken tab may then enter the patient's nasal cavity or mouth. Masks manufactured since April 2006 do not feat

FDANov 24, 2006Nationwide• Fisher & Paykel Healthcare Inc

Fisher & Paykel Healthcare Inc: Fisher & Paykel Aclaim Nasal Mask, Part Numbers: HC401A ...

Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and there is an extremely remote possibility that the broken tab may then enter the patient's nasal cavity or mouth. Masks manufactured since April 2006 do not feat

FDANov 24, 2006Nationwide• Fisher & Paykel Healthcare Inc

Fisher & Paykel Healthcare Inc: Fisher & Paykel Oracle Oral Mask, Part Numbers: 900HC451,...

Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and there is an extremely remote possibility that the broken tab may then enter the patient's nasal cavity or mouth. Masks manufactured since April 2006 do not feat

FDANov 24, 2006Nationwide• Fisher & Paykel Healthcare Inc

Fisher & Paykel Healthcare Inc: Fisher & Paykel Infinity Direct Nasal Mask, Part Numbers:...

Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and there is an extremely remote possibility that the broken tab may then enter the patient's nasal cavity or mouth. Masks manufactured since April 2006 do not feat

FDANov 24, 2006Nationwide• Fisher & Paykel Healthcare Inc

Fisher & Paykel Healthcare Inc: Fisher & Paykel FlexiFit Full Face Mask, Part Numbers: H...

Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and there is an extremely remote possibility that the broken tab may then enter the patient's nasal cavity or mouth. Masks manufactured since April 2006 do not featu

FDANov 24, 2006Nationwide• Fisher & Paykel Healthcare Inc

Fisher & Paykel Healthcare Inc: Fisher & Paykel FlexiFix Nasal Mask, Part Numbers: HC405...

Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and there is an extremely remote possibility that the broken tab may then enter the patient's nasal cavity or mouth. Masks manufactured since April 2006 do not feat

FDANov 24, 2006Nationwide• Fisher & Paykel Healthcare Inc

Elekta, Inc.: Desktop Pro R6.0 & R6.1, Linear Medical Accelerator.

Unexpected Diaphragm movement when manual field size modifications are not saved.

FDANov 23, 2006AL, AZ, CA +11 more• Elekta, Inc.

Abbott Laboratories MPG: ARCHITECT LH Reagent, each kit contains bottles of Anti-B...

The lots of ARCHITECT LH Reagent List 6C25-22, have the potential to generate patient specimen results that are elevated. Correlation studies have demonstrated an upward shift in slope for patient results of approximately 13% on average when compared to other currently available reagent lots and an average bias from patient specimens of 13% to 17% has been observed.

FDANov 22, 2006PR• Abbott Laboratories MPG

Kavo America Corporation: KaVo QUATTROcare Spray, 500 ml aerosol can; a maintenance...

The QUATTROcare Spray cans may allow the gas (propane) to escape from the can under certain circumstances. In rare cases, when an ignition source is nearby, this escape of gas may lead to the emission of smoke and possibly flames from the can which could lead to property damage or personnel injury.

FDANov 22, 2006Nationwide• Kavo America Corporation

Medline Industries Inc: Medline Premium Wet Skin Prep Tray, Sterile, Latex Free; ...

The product, labeled as sterile, had not gone through the sterilization process at the time of shipment.

FDANov 21, 2006IL, IN, MN +1 more• Medline Industries Inc

USA Instruments Incorporated: LATERAL BIOPSY PLATE - For use with the Liberty 9000, 8-...

The packaging used for the Breast Biopsy Plate may exhibit small holes or tears.

FDANov 21, 2006Nationwide• USA Instruments Incorporated

GE OEC Medical Systems, Inc: OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopi...

Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. The OEC 8800 Flexview was recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system lok-up, incorrect image display, incorrect dose area calculated air kerma in "film mod

FDANov 20, 2006Nationwide• GE OEC Medical Systems, Inc

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