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Showing 20141–20160 of 22584 results

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Stryker Howmedica Osteonics Corp.: Hoffman II compact Sterile Wrist Kit is used in the stabi...

Stryker Orthopaedics became aware that the pin of the Hoffmann II Compact External Fixation System may jam into the Soft Tissue protector.

FDAAug 17, 2005Nationwide• Stryker Howmedica Osteonics Corp.

Gambro Renal Products: Prisma continuous renal replacement system.

Critically ill patients undergoing continuous renal replacement therapy may suffer excessive fluid loss.

FDAAug 16, 2005Nationwide• Gambro Renal Products

Unknown Manufacturer: Amplatz Goose Neck Microsnare Kit, Model SK400 (175 cm l...

ev3 has determined that one test unit from each of two lots did not meet mininum tensile strength requirements and therefore the entire lots are being recalled.

FDAAug 16, 2005AL, AR, CA +11 more

International Biophysics Corp: IBC Suction Handle (Sterile), a component of Blood Recove...

Tyvek pouches containing device labeled as sterile have defective seals.

FDAAug 16, 2005FL, IN• International Biophysics Corp

Event Medical: INSPIRATION Ventilator Model Numbers: F7100000-XX, F7200...

Firm received reports of combustion within the blender system of the Inspiration Ventilator.

FDAAug 12, 2005Nationwide• Event Medical

Siemens Medical Solutions USA, Inc: Magnetom Espree. Magnetic Resonance Imaging System. model...

there is a misalignment of the patient table that may occur between the patient table and the opening to the magnet bore

FDAAug 12, 2005Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Magnetom Avanto. Magnetic Resonance Imaging System. Model...

there is a misalignment of the patient table that may occur between the patient table and the opening to the magnet bore

FDAAug 12, 2005Nationwide• Siemens Medical Solutions USA, Inc

Stryker Howmedica Osteonics Corp.: T2 Recon Nail System.

The blister pack containing the Recon 6.5 Lag Screws may become damage during shipment resulting in loss of sterility.

FDAAug 12, 2005Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Scorpio Total Knee Cruciate Retaining Femoral Component, ...

The Left Scorpio Total Knee Cruciate Retaining Waffle Femoral Component #7 packaged and labeled as left may contain a Right and vice versa.

FDAAug 11, 2005Nationwide• Stryker Howmedica Osteonics Corp.

Beckman Coulter Inc: Aqueduct Hematology Workflow Manager, software

Potentail for misidentification of historical patient results within the Aqueduct Hematology Workflow Manager software. In instances where the workflow manager software receives the same patient identifier for more than one patient the Aqueduct Workflow Manager software merges all results into one Patient File. The may cause test results to be associated with the wrong patient.

FDAAug 10, 2005AK, AZ, CA +15 more• Beckman Coulter Inc

Boston Scientific Corporation One Boston: Renegade Hi-Flo Microcatheter Kits, Catalog/Order # 18-29...

Outer box of the product may have an incorrect expiration date listed as 2007-06, while the correct expiration date is 2007-04

FDAAug 10, 2005KY, TX• Boston Scientific Corporation One Boston

Pascal Co Inc: product labeled in part: ''***banicide ADVANCED, A Reusa...

The product, Banicide Advanced, a resuable sterilizing and disinfecting solution, is likely to be ineffective for its intended use because testing found it failed testing for sporicidal use.

FDAAug 9, 2005Nationwide• Pascal Co Inc

Depuy Mitek, a Johnson & Johnson Co.: DePuy Mitek Straightshot Ligament Graft Passer/Protector,...

Mislabeled: The kit contained the incorrect Ligament Passer. The package contained a 9.5 mm instead of the labeled 11.5mm ligament passer

FDAAug 9, 2005CA, NC, VA• Depuy Mitek, a Johnson & Johnson Co.

Stryker Howmedica Osteonics Corp.: Reamer T-Handle; Non- Sterile; Howmedica Osteonics Corp.,...

Stryker Orthopaedics learned that the T-handles have the potential to not engage and not attach to the reamer properly.

FDAAug 8, 2005Nationwide• Stryker Howmedica Osteonics Corp.

Diasorin Inc.: The ETI-Mumps IgG Enzyme Immunoassay Test Kit is sold wit...

Potential for false negative results. A software anomaly may occur when performing the ETI-Mumps IgG assay on the ETI-Max 3000 automated platform. The error occurs when running a combined plate on the ETI-Max 3000, with the ETI-Mumps IgG assay as the second assay on a combined plate with ETI-Measles IgG and/or ETI-VZV IgG.

FDAAug 8, 2005Nationwide• Diasorin Inc.

Stryker Howmedica Osteonics Corp.: Navigation Reamer T-handle; Non Sterile; Howmedica Osteon...

Stryker Orthopaedics learned that the T-handles have the potential to not engage and not attach to the reamer properly.

FDAAug 8, 2005Nationwide• Stryker Howmedica Osteonics Corp.

Guidant Endovascular Solutions, Inc.: Guidant OTW OMNILINK .018 & .035 Biliary Stent Systems

This action is being taken as a preventative measure as a result of an increased rate of complaints associated with stents becoming loose or dislodged from the delivery catheter.

FDAAug 8, 2005Nationwide• Guidant Endovascular Solutions, Inc.

Biosense Webster, Inc.: Thermocool Irrigated Catheters Celsius LABEL US Part Num...

Increased complaints regarding catheters with leaks and flow obstruction.

FDAAug 8, 2005FL, IL, MA +3 more• Biosense Webster, Inc.

Trek Diagnostic Systems: VersaTREK Myco AS.

Invitro diagnostic test kit used for testing to confirm the presence of tuberculosis contains interfering bioburden which can cause false positive results.

FDAAug 8, 2005AL, IL, IN +6 more• Trek Diagnostic Systems

Abbott Laboratories MPG: ABBOTT TestPack +Plus hCG Combo, list 3A60-16; the kit co...

False Positive results may be obtained with the identified lot of list 3A60-16 when using a negative patient sample or a negative control.

FDAAug 7, 2005IN• Abbott Laboratories MPG

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