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Showing 21081–21100 of 22584 results

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Arrow International Inc: Arrow PICC Kit with Blue Flex Tip Catheter and Placement ...

Product was mislabeled for lumen configuration, flow rates, and priming volume.

FDASep 21, 2004AZ, CA, IN +2 more• Arrow International Inc

Horizon Medical Products Inc: LifePort, Dual Lumen Profile Plastic Dual Port with Poly ...

The product has an incorrectly sized introducer included in the kit. The kit contains a 12 French introducer instead of a 7 French introducer.

FDASep 20, 2004FL, GA, LA +5 more• Horizon Medical Products Inc

Fresenius Medical Care North America: Fresenius Peritoneal Dialysis Premier Luer Lock Transfer ...

Peritoneal Dialysis Transfer Set may have occluded pathway

FDASep 20, 2004Nationwide• Fresenius Medical Care North America

Smiths Medical MD, Inc.: Deltec Cozmo Insulin Pump

The vibratory alarm motor installed in a small number of Deltec Cozmo Insulin Pumps may function intermittently.

FDASep 18, 2004MD, OR• Smiths Medical MD, Inc.

bioMerieux: BacT/ALERT(BTA) Classic instruments.

Over heating of memory board.

FDASep 17, 2004Nationwide• bioMerieux

Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa: Applied Blunt Tip Trocar Models C0717 and C0718

Inadequate trocar tip assembly that might yeild parts to patients.

FDASep 17, 2004Nationwide• Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa

Toshiba American Med Sys Inc: Excelart (tm) VANTAGE P2 & P3, Magnetic Resonance Imaging...

Scanned images are acquired at a position that is shifted relative to the intended position in the slice direction due to a software anomaly.

FDASep 16, 2004AZ, AR, CA +10 more• Toshiba American Med Sys Inc

BD Opthalmic Systems: BD EdgeAhead Stiletto/MVR Knife 1.1mm (19g) REF 585240

Blade may become detached from the handle

FDASep 16, 2004Nationwide• BD Opthalmic Systems

Draeger Medical, Inc.: APL Valve used on some Fabius GS (Catalog number 4117110)...

rotating knob of the rotary style APL valve can become separated from the assembly.

FDASep 15, 2004Nationwide• Draeger Medical, Inc.

GE OEC Medical Systems, Inc: Spine Clamp, an accessory to the InstaTrak 3500 Plus syst...

Threads on this accessory spine clamp may become tight, which may make it difficult to install or remove.

FDASep 15, 2004AL, CA, CO +23 more• GE OEC Medical Systems, Inc

Medtronic Inc: Medtronic DLP VAD Venous Cannula for Ventricular Assist, ...

Spiral tip from DLP VAD cannula may be loose and potentially detach during use.

FDASep 15, 2004Nationwide• Medtronic Inc

Diopsys Inc: The Enfant Evoked Response Photic Stimulator. The Enfant...

The firm established no medical device quality system, no established quality plan and no established quality procedures.

FDASep 15, 2004CT, IN, NJ +2 more• Diopsys Inc

PerkinElmer LAS Inc: RESOLVE Hemoglobin Test Kits packed and distributed under...

The product insert for the test kits is incorrect with regard to the acceptable storage temperature for the Agarose IEF gel component. The kit and IEF gel labels indicate the correct storage temperature of 2-8 degrees C. The product insert incorrectly indicates that the product may be stored at 2-30 degrees C.

FDASep 14, 2004Nationwide• PerkinElmer LAS Inc

Merit Medical Systems, Inc: 10 ml Inject 10 Palm Pad, sterile

Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch.

FDASep 14, 2004Nationwide• Merit Medical Systems, Inc

Medtronic MiniMed: Medtronic MiniMed Paradigm Model 712

Several complaints of pumps exhibiting A47 alarms were received. Investigation revealed the alarms occurred when the pump attempted to display text that exceeded the maximum display length of the pump screen. The investigation revealed this only occurs when the pump is programmed to display information in Spanish.

FDASep 14, 2004Nationwide• Medtronic MiniMed

Merit Medical Systems, Inc: 8 ml Inject8 Coronary Control Syringe, sterile.

Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch.

FDASep 14, 2004Nationwide• Merit Medical Systems, Inc

Merit Medical Systems, Inc: Convenience Kits containing Inject8 or Inject10 syringes.

Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch.

FDASep 14, 2004Nationwide• Merit Medical Systems, Inc

Philips Ultrasound, Inc.: HDI 4000 Ultrasound System & the Philips 4000 Ultrasound ...

Potential for device to cause burning of the skin.

FDASep 10, 2004PR• Philips Ultrasound, Inc.

Unknown Manufacturer: Stockinette, Single Ply Econo Weave, 8 X 72'', Ref #9999...

Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility.

FDASep 9, 2004Nationwide

Smiths Medical ASD, Inc.: Portex Tracheostomy Tube Decannulation Cap for use only w...

Sterility of the device is compromised due to packaging defects

FDASep 9, 2004Nationwide• Smiths Medical ASD, Inc.

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