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Showing 63621–63640 of 68218 results

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Bayer Healthcare LLC: Ascensia Contour Blood Glucose Monitoring System ( Bayer ...

Incorrect Unit of Measure displayed : The meters report results in the wrong unit of measurement for Canadian users.

FDAJun 6, 2007Nationwide• Bayer Healthcare LLC

Wallach Surgical Devices, Inc.: Wallach Cryotip T-00337 Anorectal Tip used with the Cryos...

The tip may separate from the probe.

FDAJun 6, 2007Nationwide• Wallach Surgical Devices, Inc.

Unknown Manufacturer: Nonabsorbable Polypropylene Synthetic Suture-Deklene, DEK...

Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.

FDAJun 6, 2007CO, FL, IL +3 more

Unknown Manufacturer: Various Types, Sterile/Nonsterile Stainless Steel Nonabso...

Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.

FDAJun 6, 2007CO, FL, IL +3 more

Unknown Manufacturer: Various Sizes of Sterile Polygycolic Acid Synthetic Surgi...

Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.

FDAJun 6, 2007CO, FL, IL +3 more

Cardinal Health 303 Inc DBA Alaris Products: Alaris Medical Systems IV Administration Set, Low Sorbing...

The sterility of the product may be compromised as the packaging used for the sterility barrier was not designed for the sterility process used by the firm.

FDAJun 5, 2007Nationwide• Cardinal Health 303 Inc DBA Alaris Products

Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany: BrainLAB Target Positioner for Leksell Headring used with...

Target Alignment Error : A mechanical component/software incompatibility caused by a specific combination of the BrainLAB Target Positioner version 40700-3A for Leksell headrings and BrainLAB planning software resulted in a 1.25 mm shift in target area alignment during radiosurgery treatment.

FDAJun 5, 2007OH, WA• Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany

Smiths Medical PM, Inc.: BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200)

Turn off unexpectedly/ Not turn on : monitors turned off unexpectedly sounding the critical failure alarm. Advisor Vital Signs monitors that were off, would not turn back on.

FDAJun 5, 2007PR• Smiths Medical PM, Inc.

B. Braun Medical, Inc.: Thermodilution Right Heart Catheters, Catalog Numbers 604...

Cracks at the Catheter Tip

FDAJun 5, 2007Nationwide• B. Braun Medical, Inc.

Sendx Medical Inc: ABL8O FLEX Software Version 1.10 included in the ABL8O Fl...

The ABL8O FLEX software version 1.10 contains errors in the derived parameter calculation for cBase(B,ox) and cBase(Ecf,ox). These incorrect calculations result in a mild to moderate lowering of the base excess value, the severity depending on the concentration of hemoglobin and the oxygen saturation in the sample. Elevated hemoglobin concentrations have the greatest impact on this calculation err

FDAJun 4, 2007IN, OH• Sendx Medical Inc

Boston Scientific Corporation One Boston: Boston Scientific Impulse Flextrusion Shaft 5F FR4 16391-...

Labels on the carton from two batches/lots of Impulse Angiographic Catheters may indicate a different curve style than the device that is actually in the carton.

FDAJun 4, 2007Nationwide• Boston Scientific Corporation One Boston

Kimberly-Clark Corporation: Kimberly-Clark Microcuff Endotracheal Tube, Pediatric Ora...

The tubes may kink during use which may impede or prevent ventilation.

FDAJun 4, 2007Nationwide• Kimberly-Clark Corporation

Medtronic Perfusion Systems: Medtronic Performer CPB-Universal R2100375. Catologue N...

Device failure requiring use of back up systems (malfunctioning printed circuit board (PCB))

FDAJun 4, 2007AL, AZ, CA +7 more• Medtronic Perfusion Systems

Cardinal Health: AirLife nCPAP System Driver; a nasal continuous positive ...

Under isolated conditions, the device may experience issues with O2 Calibration, which may result in either a nuisance alarm or a delivered FiO2 of up to 5% below the specified tolerance.

FDAJun 1, 2007Nationwide• Cardinal Health

Quantimetrix Corporation: Quantimetrix QuanTscopics Urine Microscopics Control. Qu...

This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group.

FDAJun 1, 2007Nationwide• Quantimetrix Corporation

Quantimetrix Corporation: Quantimetrix SpinalScopics Spinal Fluid Cell Count Contro...

This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group.

FDAJun 1, 2007Nationwide• Quantimetrix Corporation

Abbott Laboratories Inc.: MULTIGENT Acetaminophen, List Number 2K99-20

Lipase results are falsely elevated when a MULTIGENT Acetaminophen test is pipetted immediately before a Lipase test from the same sample cup or tube on the ARCHITECT c8000.

FDAJun 1, 2007PR• Abbott Laboratories Inc.

The Sisus Corporation: Non-AC-powererd Patient Lifts for assisting patients whe...

Poor welding may cause the device(s) to fail, which may result in the user, falling in the bathroom and/or a lack of assistance with bathing or toileting.

FDAJun 1, 2007Nationwide• The Sisus Corporation

Quantimetrix Corporation: Quantimetrix Dip and Spin Control Urine Dipstick/Microsco...

This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group.

FDAJun 1, 2007Nationwide• Quantimetrix Corporation

Abbott Laboratories Inc.: Clinical Chemistry Lipase, List Numbers: 7D80-20 and 7D80-30

Lipase results are falsely elevated when a MULTIGENT Acetaminophen test is pipetted immediately before a Lipase test from the same sample cup or tube on the ARCHITECT c8000.

FDAJun 1, 2007PR• Abbott Laboratories Inc.

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