Baxter International Inc. said on 2/2 that the company's December 13, 2005 recall of its Colleague Volumetric Infusion Pumps has been classified by the FDA as the most serious type of recall.
The pump was recalled four times in 2005 for various problems, including battery undercharging and underinfusion which could lead to the interruption of therapy.
The recalls were classified by FDA as Class 1, meaning there is a reasonable probability that using the product may cause serious injury or death.