FDA Orders Recall of Baxter's Colleague Volumetric Infusion Pumps

The U.S. Food and Drug Administration sent a letter to Baxter Healthcare Corp. on April 30 ordering the company to recall and destroy all of its Colleague Volumetric Infusion Pumps currently in use in the United States, resulting from a longstanding failure by the company to correct many serious issues with the pumps, according to an FDA news release.

The FDA is also ordering Baxter to provide refunds to customers or to replace pumps at no cost to customers to help defray the cost of replacement, according to the release. This action follows the agency's announcement that it would be launching new initiatives to address issues with infusion pumps, which are used to deliver fluids, including anesthesia and chemotherapy medications, to patients.

The FDA has been working with Baxter since 1999 to correct numerous device flaws in the Colleague pumps, including several Class I recalls for battery swelling, inadvertent power off, service data errors and other issues, according to the release. In June 2006, the agency obtained a consent decree of permanent injunction in which Baxter agreed to stop manufacturing and distributing all models of the Colleague pump until the issues were corrected and the pumps were brought into compliance.

On Apr. 8, Baxter submitted a proposed correction schedule to the FDA that stated that the company did not plan to begin the latest round of corrections to the adulterated and misbranded pumps until May 2012, with anticipated completion of the proposed corrections in 2013. As a result, the FDA ordered the recall.

Read the FDA's release on the Baxter Colleague pump recall.