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FDA Orders Recall of Baxter Colleague Infusion Pumps

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The Food & Drug Administration (FDA) is making Baxter International recall its Colleague infusion pumps. According to the agency, the Colleague Infusion Pump recall order is based on Baxter’s longstanding failure to correct many serious problems with the devices, including battery failures and software errors.

The FDA believes there may be as many as 200,000 Colleague infusion pumps currently in use. Baxter Colleague infusion pumps have been associated with 56,000 complaints of injuries, deaths and malfunctions from 2005 to 2009, the agency said.

The FDA said it 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.

According to the FDA, Baxter last month submitted a proposed correction schedule to the agency that stated that the firm did not plan to begin the latest round of corrections to the defective pumps until May 2012, and would not be completed until 2013. The FDA deemed this plan unacceptable, and ordered the recall in accordance with the 2006 consent decree.

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