Class I recall for Colleague pumps
This article was originally published in The Silver Sheet
Executive Summary
A recent recall by Baxter was designated Class I by FDA July 18. The firm recalled 4,500 upgraded versions of its triple-channel Colleague infusion pumps in June after it received reports of 16 serious injuries resulting from an interruption of medication that occurred when pumps distributed to hospitals between May 14 and June 20 experienced a "buffer overflow." Baxter says it has identified a fix for the problem, which relates to how the product handles a combination of "intensive" commands, but is waiting on FDA to validate its corrective action before it resumes upgrading its 75,000-unit triple-channel installed base. Colleague devices experienced multiple Class I recalls in 2005 and 2006 and a seizure by FDA in October 2005 ("The Silver Sheet" October 2005)