Baxter expands recall of drug infusion pumps

CHICAGO (Reuters) - Baxter International Inc. said on Tuesday that it had expanded the recall of its Colleague and Flo-Gard drug infusion pumps to include an additional 986 devices, due to falsified service records.

In July, the company recalled 534 of the pumps after it discovered some devices sent to its Phoenix service center for repair or maintenance may have been returned to customers without work being performed on them. Three employees involved in falsifying electrical safety data were dismissed, Baxter said.

No serious injuries or patient deaths have been linked to the recall, the Deerfield, Illinois-based company said.

Customers should return affected pumps for repeat inspection and servicing and will receive loaner pumps free of charge, Baxter said. Only pumps distributed in the United States are affected.

The U.S. Food and Drug Administration in July gave the recall a Class I classification because of the potential for serious injury or death if a device malfunctions. The electronic pumps control the delivery of medication or solutions to patients.

Baxter earlier this year received clearance from U.S. regulators to resume sales of the devices following the 2005 seizure of 6,000 pumps from warehouses that were believed to have a defect that could cause them to shut down during therapy.

(Reporting by Susan Kelly)