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, according to a report in The New York Times. The article goes on to state that the Food and Drug Administration said on April 23 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. “There are just under 200,000 of these pumps in use” at hospitals and other medical facilities, a Baxter spokeswoman said on Monday. Bob Parkinson, Baxter’s chairman and chief executive, said “the situation has languished far beyond what it should have,” when speaking to shareholders on May 5, 2010.
Infusion pumps are devices most commonly found in hospitals, delivering fluids, medicine and nutritional liquids via a timing mechanism that controls the amount of medication a patient receives.
The Los Angeles Times reports that by the end of last week, the FDA had rejected Baxter’s corrective action plan for the Colleague pumps. The agency called the plan “unacceptable.” The FDA said Baxter must “recall and destroy” all of its Colleague pumps, saying the action was based on “a long-standing failure” of the company to correct serious problems with them.
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