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: |
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. 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 September 28, 2005
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