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• Baxter Infusion Pumps Recalled Because of Service Error

  Baxter Infusion Pumps Recalled Because of Service Error
  LawsuitGuru
  2 min - Mar 19, 2008
  
  Baxter Healthcare Corporation has recalled certain COLLEAGUE and FLO-GARD infusion pumps that were sent back to the company for service. These pumps may have been returned to users without the service being performed on them. The recall initially involved over 500 COLLEAGUE and FLO-GARD pumps, but it has been expanded to include approximately 2000 more pumps with certain model and serial numbers (see links below under "Additional Information"). Check the serial numbers on FLO-GARD and COLLEAGUE pumps. If a pump is affected by this recall, the pump should be taken out of service and returned to Baxter for a repeat inspection and servicing. The company says it will provide free loaner units while pumps are being serviced. Baxter Healthcare Corporation can be reached at 1-800-THE-PUMP. If a facility has sent back the units affected by this particular recall but is still using other COLLEAGUE pumps that did not get the upgrade, Baxter's previous safety notices and FDA's Preliminary Public Health Notification should be reviewed for information about earlier Baxter infusion pump recalls. Note that beginning in May 2007, some COLLEAGUE pumps got...

• Safety Recommendations for Baxter Colleague Infusion Pumps

  Safety Recommendations for Baxter Colleague Infusion Pumps
  LawsuitGuru
  1 min - May 6, 2008
  
  UPDATE: 11 July 2006 FDA notified healthcare professionals that Baxter Healthcare will stop manufacturing and distributing all models of Colleague Volumetric Infusion Pump and Syndeo Patient Controlled Analgesic Syringe Pump until the company corrects manufacturing deficiencies and is in compliance with FDA's current good manufacturing practice requirements and the Quality System regulation for devices. FDA will allow the firm to continue to provide routine service maintenance, or to replace components, parts, or accessories for the Colleague and Syndeo Infusion Pumps that were already in the hands of customers before October 12, 2005. The Colleague pump has exhibited a variety of problems, including under-infusion, battery failures, false alarms and failure to alarm. See FDA Press Release "Baxter Healthcare Corp. Signs Consent Decree with FDA; Agrees to Correct Manufacturing Deficiencies." ---------------------------------------------------------- Over the past year, Baxter Healthcare Corporation has issued four urgent safety notices and recalls for the company's Colleague infusion pump, specifying steps to be taken to address problems with the pumps. FDA is now recommending that users of Colleague pumps take certain additional safety steps: • Try not to use the Colleague pumps in situations...

• Baxter Infusion Pumps Recalled because of Service Error

  
  Baxter Infusion Pumps Recalled because of Service Error
  U.S. Food and Drug Administration
  2 min - Oct 2, 2007
  
  Baxter Healthcare Corporation has recalled certain COLLEAGUE and FLO-GARD infusion pumps that were sent back to the company for service. These pumps may have been returned to users without the service being performed on them. The recall initially involved over 500 COLLEAGUE and FLO-GARD pumps, but it has been expanded to include approximately 2000 more pumps with certain model and serial numbers (see links below under "Additional Information"). Check the serial numbers on FLO-GARD and COLLEAGUE pumps. If a pump is affected by this recall, the pump should be taken out of service and returned to Baxter for a repeat inspection and servicing. The company says it will provide free loaner units while pumps are being serviced. Baxter Healthcare Corporation can be reached at 1-800-THE-PUMP. If a facility has sent back the units affected by this particular recall but...

• Certain Baxter Dialyzers Recalled (Feb. 2002)

  Certain Baxter Dialyzers Recalled (Feb. 2002)
  LawsuitGuru
  1 min - May 7, 2008
  
  Occasionally on FDA Patient Safety News, we report on medical devices recalled by their manufacturers for safety reasons. We do this mainly for what FDA calls "Class 1 Recalls' - that is, those that represents the highest level of risk. In these cases, the manufacturer has already notified users about the recall, and we cover it during the broadcast just to be even more certain that users of the device have heard about it. The recalls we cover during these broadcasts have already been posted on a special FDA web site on recalls. Medical Device Recalls Website: http://www.fda.gov/cdrh/recalls/index.html Today we want to tell you about the recall of certain dialyzers made by Baxter Healthcare Corporation. These dialyzers were distributed widely around the world, and may have been involved in over 50 patient deaths in various countries, including the U.S. Most of the patients who died experienced shortness of breath, chest tightness, cardiac arrest, or stroke symptoms, within hours of being dialyzed. The FDA has been working closely with Baxter and with the other nations involved to identify the problems and recall the product. In mid-October, Baxter notified...