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Showing 88121–88140 of 92420 results

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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

NCR Universal Inkjet Refill Kits (NCR Corp.) – Potential Safety Issue (2004)

The recalled kits were sold in a clear plastic package with color or black ink. The black ink kits have model numbers 943264 and 999292 and the color ink kits have model number 999289 printed on the side panel above the UPC code. The two black inkjet sets contain four plastic bottles of black ink, two plastic bottles of cleaning fluid and one toolkit. The color inkjet set contains six plastic bottles of colored ink, two plastic bottles of cleaning solution and one toolkit.

CPSCSep 15, 2004Nationwide• NCR Corp., of Dayton, Ohio

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

Predator 500 ATV (Polaris Industries) – Vehicle Safety Concern (2004)

The recall includes "Predator 500" ATVs from model years 2003 and 2004 with these model numbers: A03GJ50AA, A03GJ50AB, A03GJ50AS, A03GJ50CA, A04GJ50AA, A04GJ50AB, A04GJ50AC, and A04GJ50AD. The model number is on the lower left frame tube ahead of the engine. "Predator" is prominently displayed on the right and left side of the front cab covering the fuel tank. The ATVs have red, blue, gray or black front and rear cabs.

CPSCSep 14, 2004Nationwide• Polaris Industries Inc., of Medina, Minn.

Baby Björn Baby Carrier Active (Baby Swede) – Repair Needed (2004)

The recalled infant carriers were sold under brand name "Baby Björn", which is printed on the front of the carriers and on the black molded plastic back support buckle. Model number 0260 is printed on the care label on the strap of the carrier. The carriers are made of a cotton polyester blend fabric in black with red piping and blue with white piping. "Baby Carrier Active" is written on the packaging and above the warning label on the carrier.

CPSCSep 14, 2004Nationwide• Baby Swede, LLC, of Cleveland, OH

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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