Agency cites years of problems; Baxter Healthcare ordered to offer refunds, replacements
WEDNESDAY, May 5 (HealthDay News) -- The U.S. Food and Drug Administration has notified Baxter Healthcare Corp. that the company must recall and destroy all Colleague Volumetric Infusion Pumps currently being used in the United States, which may number 200,000.
According to the FDA, the Colleague pumps have been involved in several recalls in the past decade for a number of problems. In 2006, the FDA obtained a consent decree of permanent injunction, in which the company agreed to cease manufacturing and distributing the pump until relevant issues were addressed. Subsequent changes to the pumps did not correct the issue that led to the injunction, according to the FDA.
Furthermore, the agency is ordering the company to give refunds to customers or replace the pumps at no cost. The FDA and the company plan to provide more information to hospitals and other pump users about this development.
"The 2006 consent decree gave FDA authority to take any action it deemed appropriate. The FDA has determined that this action is necessary, as Baxter has failed to adequately correct, within a reasonable timeframe, the deficiencies in the Colleague infusion pumps still in use. Therefore the FDA is now ordering Baxter to: recall and destroy all Colleague infusion pumps; reimburse customers for the value of the recalled device; [and] assist in finding a replacement for these customers," the agency said in a news release.
More Information