Baxter expands recall of drug infusion pumps
CHICAGO (Reuters) - Baxter International Inc. said on Tuesday it expanded the recall of its Colleague and Flo-Gard drug infusion pumps first announced in July to include an additional 986 devices.
The company last month 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 should a device malfunction. The electronic pumps control the delivery of medication or solutions to patients intravenously.
Baxter in April began correcting defects in existing Colleague infusion pumps, after receiving approval from U.S. regulators, following the 2005 seizure by authorities of 6,000 pumps thought to have a defect that could cause them to shut down or deliver the wrong amount of medication.
There are about 275,000 Colleague pumps in use in hospitals worldwide, with more than 200,000 of those in the United States, according to Baxter.
The company must complete a quality audit process with regulators before it can sell any new Colleague pumps. The company has not set a timeline for when it may resume sales of the product but has said it does not expect any sales in 2007, a Baxter spokeswoman said.
Shares of Baxter were down 47 cents at $53.50 in afternoon trading on the New York Stock Exchange. The shares are down 9.3 percent after reaching a five-year high of $59.00 in July.
(Reporting by Susan Kelly)
