Baxter International Inc. has been ordered to recall 200,000 Colleague brand pumps. FDA has called on the company to "recall and destroy" all of the pumps in the product line because Baxter has shown "a longstanding failure" to correct serious problems with the devices. The failure will be costly too—the company will incur a special pretax charge of $400 million to $600 million to cover recall costs.

"The situation has languished far beyond what it should have," said Baxter's CEO and chairman Bob Parkinson yesterday at the company's annual meeting in Deerfield, IL.

Over the past five years, FDA has received more than 56,000 adverse-event reports involving infusion pumps, including serious injuries and more than 500 deaths. The agency launched an initiative less than two weeks ago to address pump safety and issued a draft guidance soon after.