
Baxter Healthcare Corp. has received a second Food & Drug Administration Class 1 recall in less than four months for its Colleague Volumetric Infusion Pumps. The FDA's Sept. 19 recall relates to pump battery excessive discharge and swelling failures, which cause the devices to become incapable of operating on battery power for the expected amount of time. This leads to interruption or prevention of therapy and possible death or injury. Baxter said it has received reports from customers that the problem may have been associated with four deaths and 10 serious injuries.