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Showing 65481–65500 of 68218 results

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Gish Biomedical Inc: The GISH Vision Blood Cardioplegia System with GBS coatin...

The coated Gish Vision Blood Cardioplegia Systems are associated with an increased incidence of heat exchanger leaks.

FDANov 28, 2005CA, FL, IN +4 more• Gish Biomedical Inc

Fresenius Medical Care North America: Optiflux Series Fresenius Polysulfone F160NR dialyzer ...

Mislabeled: Inner product mislabeled as F180NR (Catalog Number 0500318N) instead of F160NR

FDANov 28, 2005Nationwide• Fresenius Medical Care North America

Gish Biomedical Inc: The GISH Vision Hollow Fiber Oxygenator with GBS coating ...

Gish received four reports of potential leakage. All reports were associated with GBS coating. There was no patient injury reported.

FDANov 28, 2005Nationwide• Gish Biomedical Inc

Becton Dickinson & Co.: BBL GasPak Pouch System and BBL GasPak CampyPouch Syste...

Microbiological based test system may be contaminated with bacteria and cause false clinical test results in patient samples.

FDANov 23, 2005Nationwide• Becton Dickinson & Co.

Beckman Coulter Inc: Cytomics FC500 with CXP Software

Under certain conditions an incorrect Tube ID (Barcode) can be displayed and printed on the Runtime Panel Report in CXP Cytometer Software Version 2.0

FDANov 23, 2005Nationwide• Beckman Coulter Inc

Varian Medical Systems Inc: Varian brand Radiation Therapy Linear Accelerator VARiS; ...

The export of multi-static segment BrainLab M 3 MLC from VARiS Vision may produce undesirable result, which could lead to mistreatment.

FDANov 23, 2005AZ, AR, CA +33 more• Varian Medical Systems Inc

Medtronic Inc, Neurological & Spinal Division: Medtronic Model 37711 Restore Neurostimulator. The Resto...

A limited number of Model 37711 Restore Neurostimulators have an incorrect internal memory parameter that causes the device to indicate it is fully recharged when it may only be 80% to 90% recharged. This anomaly does not affect patient safety. This anomoly can be corrected by reprogramming the Restore Neurostimulator using specific software.

FDANov 22, 2005Nationwide• Medtronic Inc, Neurological & Spinal Division

AGFA Corp.: CR QS (versions 3.0.207, 2.0.210 SU1, 3.0.229) ADC QS and...

Users of affected systems may experience one or more of four (4) problems the clinical impact could be a loss of image(s), the need to repeat the imaging procedure and, possibly, a short delay in diagnosis.

FDANov 18, 2005Nationwide• AGFA Corp.

Olympus America, Inc: OLA 2500 Olympus Lab Automation Systems to include the fo...

Lab Automation System may dilute samples with water.

FDANov 18, 2005Nationwide• Olympus America, Inc

Medex Inc: MX6160R1, Custom CIPER (Comprehensive Intracranial Presss...

The product is labeled as 'Latex Free'; however, one of the components of the finished product may contain latex.

FDANov 18, 2005AL, IN• Medex Inc

Stryker Endoscopy: StrykeFlow II Disposable Suction/Irrigator; AHTO Tube Set...

Devices for which sterility may be compromised as evidenced by a crack in the package.

FDANov 18, 2005Nationwide• Stryker Endoscopy

AGFA Corp.: ADC Solo & Initia CR 1000, Path Speed CR SP1001, Centrici...

Users of affected systems may experience a loss of images, the need to repeat the imaging procedure and possibly a short delay in diagnosis.

FDANov 18, 2005Nationwide• AGFA Corp.

Philips Medical Systems: HeartStart Pads Pediatric Plus, Pediatric Plus Multifun...

The Apex/Anterior and the Sternum/Posterior pad labels are located in reverse position to the wire and connector

FDANov 18, 2005Nationwide• Philips Medical Systems

Medex Inc: MX441B, CVP Manometer. The product is packaged in a card...

The product is labeled as 'Latex Free' , however,one of the components of the finished product may contain latex.

FDANov 18, 2005IN• Medex Inc

Baxter Healthcare Renal Div: System 1000 family of Hemodialysis Instruments, including...

Potential for fluid or air to be passed through the venous line clamp if the tubing is not centered in the clamp and extends beyond the edge of the clamp's pinch zone. This could result in an air emboli condition.

FDANov 18, 2005Nationwide• Baxter Healthcare Renal Div

Respironics California Inc: The PL V Continuum ventilator is a microprocessor control...

During product testing of the PLV Continuum Ventilator's Safety Valve/Pressure Relief Valve (SV/PRV) at our manufacturing facility, Respironics found that when the PLY Continuum Ventilator is operated in the 'Face Up' orientation, the SV /PRV may stick in the open position, which may result in loss of delivered gas volume to the patient.

FDANov 18, 2005Nationwide• Respironics California Inc

Smiths Medical ASD, Inc.: A1272-17 Portex Epidural Mini-pack

Tray may contain holes compromising the sterility of the device

FDANov 17, 2005Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: 4950-17 Portex Epidural Mini-pack

Tray may contain holes compromising the sterility of the device

FDANov 17, 2005Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: 4954-16 Portex Epidural Mini-pack

Tray may contain holes compromising the sterility of the device

FDANov 17, 2005Nationwide• Smiths Medical ASD, Inc.

Becton Dickinson & Company: BD Perisafe catheter with catheter connector. The cathet...

The catheter connector could not be sufficiently tightened to secure the catheter tubing.

FDANov 17, 2005Nationwide• Becton Dickinson & Company

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