The FDA has ordered Baxter International (NYSE: BAX) to recall and destroy its Colleague infusion pumps from the U.S. market based on what the agency calls the company's "longstanding failure" to fix serious problems. In addition, Baxter must provide refunds or free replacement pumps to customers affected by the recall. Shares of Baxter, which closed at $47.50, were slightly lower at $47.45 after hours, according to Reuters.
In a release, the FDA says it sent a letter to Baxter Healthcare April 30 ordering the company to recall and destroy all of its Colleague Volumetric Infusion Pumps currently in use in the U.S. The agency believes there may be as many as 200,000 of those pumps currently in use.
The recall is pursuant to an order under Baxter's June 2006 consent decree with the FDA. In a statement, the company says the consent decree permits it to propose alternative actions to achieve the FDA's objectives, and the final nature of the recall and offer to customers remain subject to that ongoing dialogue.
But the FDA points out that Baxter submitted a proposed correction schedule April 8 stating the company didn't plan to begin the latest round of corrections to the adulterated and misbranded pumps until May 2012. The proposal also said Baxter doesn't anticipate the completion of the proposed corrections until 2013. On that schedule, a device with known safety concerns would remain in use on patients needing specialized care until 2013, and the FDA finds this unacceptable.
Infusion pumps, including the Baxter Colleague models, have been the source of persistent safety problems, the agency adds. In the past five years, the FDA has received more than 56,000 reports of adverse events associated with the use of infusion pumps. Those events have included serious injuries and more than 500 deaths. Between 2005 and 2009, 87 infusion pump recalls were conducted to address identified safety concerns, according to FDA data.
Baxter currently anticipates that it will record a pre-tax special charge of $400 million to $600 million in the first quarter for the reasonably estimable cost of the recall. The company is not otherwise revising its earnings guidance for the year in connection with the recall.
- get the FDA's statement
- read Baxter's release
- check out Reuters coverage