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Showing 66721–66740 of 68218 results

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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

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

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

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

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: 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

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: 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.

Smiths Medical ASD, Inc.: Portex ULTRA-FLO 4 - Way Stopcock Catalog Number: T1209

Sterility of the device is compromised due to packaging defects

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

Unknown Manufacturer: Impervious Stockinette, Large, 12'' X 48'' or 12'' X 54''...

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

FDASep 9, 2004Nationwide

Smiths Medical ASD, Inc.: Portex Dual-Axis Swivel Adapter Catalog Number: 525151

Sterility of the device is compromised due to packaging defects

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

Smiths Medical ASD, Inc.: Fiberoptic Bronchoscope Dual-Axis Swivel Adapter Catalog...

Sterility of the device is compromised due to packaging defects

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

Smiths Medical ASD, Inc.: Hypodermic Needle-Pro 5 ml Syringe, 21g x 1'' Needle C...

Sterility of the device is compromised due to packaging defects

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

Smiths Medical ASD, Inc.: Portex Lo-Profile Tracheostomy Tube Decannulation Cap Ca...

Sterility of the device is compromised due to packaging defects

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

Unknown Manufacturer: Stockinette, Single Ply, Standard Weave, 8 X 72'' and 10 ...

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

FDASep 9, 2004Nationwide

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