TUESDAY, Feb. 27, 2007 (HealthDay News) -- The U.S. Food and Drug Administration has approved Baxter Healthcare Corp.'s redesign for its Colleague infusion pumps, used to deliver medications and fluids intravenously.
The FDA ordered 6,000 of the original pumps seized from Baxter warehouses in October 2005, citing a number of defects that the agency said could have shut the pumps down prematurely, or under- or over-delivered medication.
In a statement Tuesday, the agency said it had approved Baxter's modified pump, among the most commonly used infusion pumps in the United States. The updated pump will include a newly designed battery protection circuit and updated software to warn of battery depletion problems, the FDA said.
In its own statement, Baxter said it was prepared to modify thousands of Colleague pumps that were allowed to remain in U.S. hospitals past 2005, under a modified set of use instructions provided by the company.
More information
Visit the FDA to learn more about Tuesday's action.
