SILVER SPRING, Md. The Food and Drug Administration is ordering medical supply manufacturer Baxter Healthcare to recall and destroy all of its Colleague volumetric infusion pumps, citing various safety issues, the agency said Monday.
The FDA said the order was based on a “longstanding failure to correct many serious problems” with the Colleague pumps and said the Deerfield, Ill.-based company would have to replace the recalled pumps at no cost to customers. The pumps are widely used in hospitals, clinics and in home health care, and the agency thinks there may be as many as 200,000 currently in use.
The agency said it has been working with Baxter since 1999 on “numerous” device flaws and since then, Colleague pumps have been subject to numerous recalls due to battery swelling, inadvertent power off, service data errors and other issues. In June 2006, the FDA obtained a consent decree of permanent injunction that forbade Baxter to manufacture or distribute the pumps until it corrected the manufacturing problems and brought the pumps into compliance. In April of this year, Baxter told the FDA that it did not plan to begin correcting the pumps until May 2012, with completion accepted in 2013, a proposal the FDA called “unacceptable.”
Baxter issued a statement Monday saying that it would comply with the recall, which it estimated would cost between $400 million and $600 million.
“Baxter will work with the FDA to ensure that the recall process provides customers appropriate alternatives for supporting patients’ needs,” the company statement read.