WASHINGTON, May 4 (UPI) — The U.S. Food and Drug Administration says it has ordered the Baxter Healthcare Corp. to recall and destroy all of its Colleague Volumetric Infusion Pumps.
FDA officials said the action is based on the company’s “longstanding failure” to correct many serious problems with the pumps. The FDA said there may be as many as 200,000 infusion pumps currently in use in the United States. The federal agency also ordered Baxter to provide refunds to customers or replace pumps at no cost.
Infusion pumps are devices that deliver fluids, including nutrients and medications, into a patient’s body in a controlled manner. They are widely used in hospitals, other clinical settings and, increasingly, in homes because they allow a greater level of accuracy in fluid delivery.
The FDA said it’s been working with Baxter since 1999 to correct numerous device flaws. Last month Baxter submitted a proposed correction schedule to the FDA that stated Baxter did not plan to begin the latest round of corrections to the pumps until May 2012.
“The proposal also stated that Baxter does not anticipate completion of the proposed corrections until 2013,” the federal agency said. “On that schedule, a device with known safety concerns would remain in use on patients needing specialized care until 2013. FDA found this proposal unacceptable.”
Last month the FDA announced it was starting an initiative to address safety problems associated with infusion pumps.
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