The Food and Drug Administration has ordered Baxter Healthcare Corp. to recall all of its Colleague infusion pumps because of a long history of malfunctions. The pumps are used to regulate the flow of medication and nutrients to patients in hospitals and at homes. About 200,000 are in use in the United States, according to the FDA.
The problems with the pumps include battery swelling, accidental shutoff and data errors; the agency said it has been working with Baxter to correct a number of the flaws since 1999. The FDA ordered the recall and destruction of all the pumps currently in use. According to a statement from the company, the recall will cost between $400 and $600 million.
The recall comes as part of the FDA’s increased scrutiny of infusion pumps. In the last five years, the devices have been linked to more than 500 deaths.


