Federal regulators say they have ordered Baxter International to recall all of its Colleague infusion pumps, devices that deliver medicine and intravenous fluids.
The Food and Drug Administration said in a statement Monday that it ordered the pumps be recalled from the U.S. market and destroyed because of what it said was the company's "longstanding failure" to fix serious problems with the pumps.
The FDA said it believes there may be as many as 200,000 of the pumps in use. The agency also ordered Baxter to give refunds or replacement pumps to customers at no cost.
The company, based in Deerfield, Ill., said it will book a pre-tax charge of $400 million to $600 million in the first quarter for the recall.
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