Date Recall Initiated |
June 20, 2007 See also: December 13, 2005, Recall for Baxter COLLEAGUE® and COLLEAGUE® CX Volumetric Infusion Pumps |
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Product: |
Upgraded Colleague® Triple Channel Volumetric Infusion Pumps, Model Numbers 2M8153, 2M8163, and 2M9163 From May 14, 2007 through June 18, 2007, Baxter distributed 4,512 infusion pumps to 420 customers (distributors and medical facilities) within the U.S. and to 7 customers outside the U.S. |
Use: |
Electronic infusion pumps deliver 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 Corp. Rt. 120 & Wilson Rd. Round Lake, Illinois 60073 |
Reason for Recall: |
A software irregularity causes the newly upgraded COLLEAGUE® Triple Channel Volumetric Infusion Pumps to alarm, display an error code (16:310:867:0002) and stop the infusion in all three channels. This occurs during user programming with all three channels infusing fluids at the same time. In reported cases, the pump stopped infusing which caused it to activate an audible and a visual alarm. |
Public Contact: |
Patients may call Center for One Baxter at 1-800-422-9837. |
FDA District: |
Chicago |
FDA Comments: |
Class 1 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.
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Updated August 8, 2007
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