Baxter Healthcare Corp. recalled all models of its Colleague Volumetric Infusion Pumps because they can shut down while delivering medication and fluids to patients, said the Food and Drug Administration. The FDA has deemed the situation a Class I recall, the most serious type.
Baxter received six reports of serious injury and three reports of deaths associated with the problem, the FDA said. The company has stopped shipping the pumps until the problems are resolved. In March, Baxter advised customers to stop using pumps that exhibited specified failure codes. Approximately 255,000 of the pumps are in use, including 206,000 in the U.S., but users should not at this time return the pumps to Baxter, the FDA said.