Friday, May 7, 2010

FDA Orders Recall and Destruction of Baxter Colleague Infusion Pumps

Updated August 25, 2016:

You might also be interested in this FDA communication:
Syringe Pump Problems with Fluid Flow Continuity at Low Infusion Rates Can Result in Serious Clinical Consequences: FDA Safety Communication

- -  original post follows below  - -

Uh-oh. The FDA believes there may be as many as 200,000 of these pumps currently in use. And they want them recalled and destroyed, as announced in FDA Issues Statement on Baxter’s Recall of Colleague Infusion Pumps.

The FDA has been working with Baxter since 1999 to correct numerous device flaws. Since then, Colleague pumps have been the subject of several Class I recalls for battery swelling, inadvertent power off, service data errors, and other issues. In June 2006, the FDA obtained a consent decree of permanent injunction in which Baxter agreed to stop manufacturing and distributing all models of the Colleague pump until the company corrected manufacturing deficiencies and until devices in use were brought into compliance. Since then, Baxter has made numerous changes to the Colleague pumps but these changes have not corrected the product defect leading to the permanent injunction.

If you have questions about what this might mean for you, then read this, FDA - Questions and Answers About the Baxter Colleague Recall, Refund, and Replacement Action.

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