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Showing 64421–64440 of 68218 results

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Cardinal Health: Convertors Tiburon Cardiovascular Split Drape II, Sterile...

The cardiovascular drape may tear and/or fray at the reinforced fenestrated trough area during use.

FDASep 27, 2006Nationwide• Cardinal Health

Teleflex Medical: Sheridan Preformed Cuffed Nasal Tracheal Tube, 7.5 mm; a ...

Biological indicator failed. Investigation eliminated all equipment and product related factors.

FDASep 27, 2006Nationwide• Teleflex Medical

Cardinal Health: Presource Custom Sterile Packs containing the Cardiovascu...

The cardiovascular drape may tear and/or fray at the reinforced fenestrated trough area during use.

FDASep 27, 2006Nationwide• Cardinal Health

Dade Behring, Inc.: Dade Behring brand MicroScan Prompt Inoculation System-D;...

Product does not meet performance specifications through its standardized inocula for MicroScan Dried Gram-Negative and Gram-Positive Overnight panel testing.

FDASep 27, 2006Nationwide• Dade Behring, Inc.

Teleflex Medical: Sheridan Sher-I-Bronch Endobronchial Tube, Left-Sided, 37...

Biological indicator failed. Investigation eliminated all equipment and product related factors.

FDASep 27, 2006Nationwide• Teleflex Medical

Invacare Corporation: AC-powered Adjustable Hospital Bed. (ICCG Bed) Affected M...

The incorrect caution label that describes washing instructions was applied to beds distributed in the US, i.e. the specified label is P/N 1116654 (English translation); the label that was used is P/N 1119165 (French translation).

FDASep 27, 2006Nationwide• Invacare Corporation

ICU Medical, Inc.: Orbit 90 Subcutaneous Infusion Set, 9 mm Catheter, 42" Tu...

The product contains a female luer which has been reported to crack in use allowing fluid to leak from the device.

FDASep 26, 2006CA, GA, OH +2 more• ICU Medical, Inc.

Abbott Laboratories Inc.: Phenobarbital- Reagent-Clinical Chemistry--List number: 1...

Erratic elevated results and or the inability to calibrate due to imprecision.

FDASep 26, 2006Nationwide• Abbott Laboratories Inc.

Belcher Pharmaceuticals Inc.: Product is Mucotrol Concentrated Oral Gel Wafer contained...

Processing and cleaning process validation were not completed before production. Product had some GMP failures related to the quality system.

FDASep 25, 2006Nationwide• Belcher Pharmaceuticals Inc.

Abbott Point Of Care Inc.: i-STAT G3+ Cartridge: PCO2 Abbott Point of Care, Princeto...

Certain lots of G3+ cartridges may be difficult to fill.

FDASep 25, 2006Nationwide• Abbott Point Of Care Inc.

Varian Medical Systems Inc: 4D Integrated Treatment Console and Varis 1.4g Medical Ch...

Selecting an empty space next to the ''Override'' or ''Acquire Actual'' buttons may result in mistreatment to the patient.

FDASep 21, 2006Nationwide• Varian Medical Systems Inc

Stryker Howmedica Osteonics Corp.: Triathlon Total Knee system Primary Tibial Baseplate #5 B...

Stryker Orthopaedics became aware that one lot of the Triathlon Primary Beaded PA Baseplate Size 5 may not have the Peri-Apatite coating.

FDASep 21, 2006AL, GA, OR +3 more• Stryker Howmedica Osteonics Corp.

Philips Medical Systems: M3001A Philips Multi Measurement Server (MMS)

Unexpected pulse oximetry (Sp02) readings (100%) over time when a sensor is not attached to the patient. In addition, with a sensor attached to a patient, an incorrect high Sp02 may be displayed when a pulse rate is in a range of 185BPM

FDASep 21, 2006Nationwide• Philips Medical Systems

Advanced Bionics Corporation 12740 San Fernando Rd Bldgs. 1 & 3 Sylmar CA 91342: Advanced Bionics Precision Linear Leads, part of the Prec...

A small number of unimplanted Precision Linear Leads may have been assembled with incorrect electrode material. At high stimulation levels, the metal may corrode and dissolved metals may enter the patient.

FDASep 21, 2006Nationwide• Advanced Bionics Corporation 12740 San Fernando Rd Bldgs. 1 & 3 Sylmar CA 91342

Philips Medical Systems: M1020B PulseOximetry Module Philips FAST Sp02 and Pulse O...

Unexpected pulse oximetry (Sp02) readings (100%) over time when sensor is not attached to patient. In addition, with a sensor attached to a patient, an incorrect high Sp02 may be displayed when a pulse rate is in a range of 185BPM

FDASep 21, 2006Nationwide• Philips Medical Systems

Boston Scientific Corp: Boston Scientific 10 Fr (3.3 mm) Flexima Regular APDL All...

Sterility compromised/package integrity : the bottom of the Tyvek pouch may not have been sealed.

FDASep 21, 2006Nationwide• Boston Scientific Corp

Cook, Inc.: Cook Zilver 635 Biliary Stent - Expanding Stent, delivery...

The side of the boxes give incorrect sizes for these stents. The label front is correct. (side label-5x40-front label-8x40)

FDASep 21, 2006ID, IN• Cook, Inc.

Drew Scientific Group PLC: Bayer Advia 70 Hematology Analyzer, manufactured by Drew ...

System has given inaccurate readings when running samples that trigger an extra rinse due to very high WBC, RBC or Platlet counts.

FDASep 20, 2006FL, MA, MN +5 more• Drew Scientific Group PLC

USA Instruments Incorporated: 3.0T HD Head Neck Spine Array, Model 2415545, for GE 3....

The firm determined that certain potential conditions for use of their medical device, outside of recommended practices, or operating manual descriptions, could result in a localized RF burn and/or electrical shock to a patient on which the device is being used.

FDASep 20, 2006CA, FL, IA +6 more• USA Instruments Incorporated

Drew Scientific Group PLC: Drew Excell 22 Hematology Analyzer, manufactured by Drew ...

System has given inaccurate readings when running samples that trigger an extra rinse due to very high WBC, RBC or Platlet counts.

FDASep 20, 2006FL, MA, MN +5 more• Drew Scientific Group PLC

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