Baxter Gets FDA Okay for Colleague Pump

Baxter International of Deerfield, IL announced Tuesday that it has received marketing clearance from the FDA for a drug infusion pump it stopped selling when defects were found, according to the Associated Press.

The agency cleared Baxter’s Colleague infusion pump after conditionally approving the company’s plan to correct defects in the pump.

In September 2005, the pumps were recalled and the FDA seized pumps at two facilities that October. The recalled occurred after battery problems were linked to four deaths.

The pumps deliver controlled amounts of intravenous drugs to patients. Baxter plans to modify pumps already on the market and will submit documentation to the FDA on the modifications.

More than 200,000 Colleague infusion pumps are being used in US hospitals. Outside the US, the company has already upgraded 58,000 pumps in 55 countries.