Baxter International is recalling its Colleague infusion pumps from the American market under an agreement with federal regulators that sought to fix problems like battery failures and software errors. The FDA has said previously that infusion pumps used to administer drugs and liquids were linked to more than 56,000 complaints of injuries, deaths and malfunctions from 2005 to 2009. The Baxter Healthcare Corporation, the company’s principal American subsidiary, has been under a consent decree with the FDA since June 2006 that allowed the agency to require a recall of the pumps.
Baxter says there are just under 200,000 of these pumps in use at hospitals and other medical facilities. The Colleague pumps, which have not been sold to new customers since 2005, will be phased out, according to the company. The FDA on April 30th rejected as “unacceptable” a plan by Baxter to keep the Colleague pumps in use until 2013 and ordered the recall. Baxter expects to offer to exchange its Sigma Spectrum infusion pumps for the Colleague pumps. The pumps are used in hospitals to deliver nutrients to patients in comas, blood-thinning drugs to heart patients, and chemotherapy to cancer patients.
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