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U.S. Department of Health and Human Services

Medical Devices

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Baxter Healthcare Corporation COLLEAGUE® Volumetric Infusion Pumps

Class 1 Recall

Date Recall
Initiated:
September 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 pump’s batteries have been known to experience battery swelling and/or excessive discharge failures. Both of these failures will result in irreversible damage to the battery. If either one of these failures occurs, the pump would be incapable of operating on battery power for the expected amount of time, thus leading to interruption or prevention of therapy and the possible death and/or serious injury of patients. Additionally, it should be noted that when the batteries become damaged due to excessive discharge, the battery charge level indicator will overstate the amount of battery charge remaining.

 

Public Contact:

Center for One Baxter
Baxter Healthcare Corporation
1 Deerfield Parkway
Deerfield, IL 60015
800-422-9837

 

FDA District:

Chicago

 

FDA Comments:
  • This recall does not require the return of infusion pumps currently in the market.
  • Baxter has advised health care institutions to have a backup pump available to mitigate any disruptions of infusions of life-sustaining drugs or fluids.
  • In an Important Product Information Letter dated February 25, 2005, Baxter notified its users of the actions they can take to minimize the occurrence of these device failures, including following proper battery maintenance procedures. Baxter's letter to customers is available.
  • On July 21, 2005 Baxter announced that the company would voluntarily hold shipments of new pumps until issues are resolved. Baxter continues to address this issue as part of its remediation efforts.

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 with questions may contact the company at 1-(847) 843-7867.
There is an FDA press release announcing the Baxter COLLEAGUE® Volumetric Infusion Pumps recall