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U.S. Department of Health and Human Services

Medical Devices

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Baxter Healthcare Corp. COLLEAGUE® Volumetric Infusion Pumps

Class 1 Recall
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.

See the FDA press release announcing the Baxter COLLEAGUE® Volumetric Infusion Pumps recall.
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