The change comes after 710 deaths associated with malfunctioning infusion pumps used in homes and hospitals during the last five years, according to American Medical News. The agency has received 56,000 adverse-event reports regarding the devices during that time period and issued 87 recalls -- 14 of those in the FDA's highest-risk class I category.
The FDA said Baxter must "recall and destroy" all of its Colleague pumps, saying the action was based on "a long-standing failure" of the company to correct serious problems with them, the LA Times reported. Baxter issued a corrective action plan, however the FDA found it wanting, responding with the order for recall.
As the LA Times reported:
The agency called the plan "unacceptable" and said it would have allowed the company to keep a device with "known safety concerns" on the market until 2013. The FDA said it was not satisfied with Baxter's timetable for fixing Colleague, a pump the company stopped selling in 2005 because of various design flaws, battery failures and related software issues.
"The FDA has been working with Baxter since 1999 to correct numerous device flaws," the agency said in a statement. "Since then, Colleague pumps have been the subject of several Class I recalls for battery swelling, inadvertent power off, service data errors and other issues."
Based on a consent decree with FDA, Baxter hasn't sold the pumps directly since 2006, but they still remain on the market.
Personally I like Hospira's plum pumps, but I doubt we'd be able to get a hospital's worth for free ....