The US Food & Drug Administration (FDA) has issued a letter to Baxter Healthcare to recall and destroy all of its Colleague Volumetric Infusion Pumps in use in the USA.
The FDA is also ordering Baxter to provide refunds to customers or replace pumps at no cost to customers to help defray the cost of replacement, and to help them find replacement pumps.
The action was taken because of Baxter's failure in correcting many serious problems with the pumps, the FDA says.
Further instruction and information from Baxter and the FDA regarding their transition will be released soon to hospitals and other users of Baxter's Colleague pumps.
Since 1999, Colleague pumps have been the subject of several Class I recalls for battery swelling, inadvertent power off, service data errors and other issues.
Baxter, however, agreed to correct the problems in all Colleague pumps in June 2006 and since then these changes have not corrected the problems, the agency said.
Baxter submitted a proposed correction schedule to the FDA stating that it does not anticipate completion of the proposed corrections until 2013, which led the FDA to authorise a permanent injunction.
To address safety problems associated with infusion pumps, the FDA took a new initiative to establish additional premarket requirements that manufacturers will be expected to meet before device submissions.
