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FDA > CDRH > Medical Device Recalls > Class I Recall - Baxter Healthcare Corp. COLLEAGUE® Volumetric Infusion Pumps

Medical Device Recalls
Class I Recall: Baxter Healthcare Corp. COLLEAGUE® Volumetric Infusion Pumps

Date Recall Initiated:	July 19, 2005
Product:	All models of Baxter Healthcare Corp. COLLEAGUE® Volumetric Infusion Pumps. Affected Models are: 2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, and 2M8163R.
Use:	These electronic infusion pumps are used to give controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural or other direct line into the bloodstream.
Recalling Firm:	Baxter Healthcare Corporation Rt. 120 & Wilson Road Round Lake, IL 60073
Reason for Recall:	The pumps can shut down while supplying critical medication and fluids to patients. Critically ill patients needing continuous delivery of life-sustaining medications at the time of the pump’s failure could be seriously harmed.
Public Contact:	Center for One Baxter Baxter Healthcare Corporation 1 Deerfield Parkway Deerfield, IL 60015 800-422-9837
FDA District:	Chicago
Advice to Users:	Baxter advised customers on March 15, 2005, to stop using any pumps that exhibit a failure code beginning with 402, 403, 533, 535, or 599, related to these electronic problems. Baxter also advised customers to take out of service any pumps that exhibit failure codes 810:04 and 810:11 related to air-in-line sensor problems, until they are inspected by authorized service personnel. These failures may occur during the infusion of therapy, so it is imperative that health care institutions have a contingency plan to mitigate any disruptions of infusions of life-sustaining drugs or fluids. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.
	Consumers who have questions about the recall may contact Baxter Healthcare at 1-800-422-9837. Those who have technical questions may contact Baxter Healthcare at 1-800-THE-PUMP (800-843-7867). Baxter's letters to customers are available on its web site at www.Baxter.com. The FDA press release announcing the Baxter COLLEAGUE® Volumetric Infusion Pumps recall is available at http://www.fda.gov/bbs/topics/NEWS/2005/NEW01209.html.

Updated July 22, 2005

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