LOS ANGELES Baxter International Inc said on Monday it will recall its Colleague infusion pumps from the U.S. market on an order from the Food and Drug Administration under the company's June 2006 consent decree with the agency.
Baxter said it will record a special pre-tax charge of $400 million to $600 million in the first quarter for the estimated cost of the recall.
The Deerfield, Illinois-based company said it would not otherwise revise its earnings outlook for the year.
The recall affects around 200,000 pumps, according to Baxter spokeswoman Erin Gardiner.
The FDA said it sent a letter to Baxter on April 30 ordering the company to recall and destroy all of its Colleague pumps in use in the United States and to provide refunds to customers or replace pumps at no cost.
"This action is based on a long-standing failure to correct many serious problems with the pumps," the FDA said in a statement.
The regulatory agency said it had been working with Baxter since 1999 to correct numerous device flaws.
Electronic infusion pumps -- used to intravenously deliver fluids, such as medication or nutrients -- have come under scrutiny by the FDA, which said last month it would establish additional requirements for manufacturers.
Authorities in 2005 seized more than 6,000 of the Colleague pumps thought to have a defect that could cause them to shut down or deliver the wrong amount of medication, causing patient injuries or deaths.
Baxter said it expects to offer customers the exchange of a recalled pump for one of the company's Sigma Spectrum pumps at no charge, although it is still negotiating with the FDA any actions to be taken.
Shares of Baxter, which closed at $47.50 on the New York Stock Exchange, were slightly lower at $47.45 after hours.
(Reporting by Deena Beasley; editing by Carol Bishopric)