profession
Baxter infusion pumps recalled
NEWS IN BRIEF — Posted May 17, 2010
The Food and Drug Administration in early May ordered Baxter Healthcare Corp. to recall and destroy all of its approximately 200,000 Colleague Volumetric Infusion Pumps on the market. The pumps have been the subject of several recalls since 1999 for inadvertently shutting off, battery problems and data errors. Baxter must reimburse its customers for the value of the pumps and help them find replacement devices.
Baxter sent the FDA a plan to fix the problems but said it would not be able to complete its corrections until 2013. The agency said in a statement that the time frame, given the gravity of the problems, was "unacceptable."
In April, the FDA announced tighter scrutiny of all infusion pumps due to 56,000 adverse-event reports and 87 device recalls in the last five years. Infusion pumps, as a class, have been associated with 710 deaths during that time period, the FDA said.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2010/05/17/prbf0517.htm.
