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: |
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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