Baxter says FDA seizes nearly 7,000 pumps
Posted on: Thursday, 13 October 2005, 08:54 CDT
NEW YORK (Reuters) - Baxter International Inc., which earlier this year stopped shipment of a line of intravenous pumps to deal with battery issues, on Thursday said U.S. regulators seized nearly 7,000 of the medical devices.
The U.S. Food and Drug Administration seized about 6,000 Baxter-owned Colleague Volumetric Infusion Pumps and about 850 Syndeo PCA Syringe Pumps, the Deerfield, Illinois-based company said.
Baxter, which saw its shares fall nearly 3 percent, said the seizure only affects its inventory, and not products already on the market. About 250,000 Colleague infusion pumps are currently in use worldwide, including more than 200,000 in the United States, it said. About 5,000 Syndeo pumps, which allow patients to administer pain analgesics, are in use worldwide.
Baxter said it had placed a voluntary hold on shipments of new Colleague and Syndeo pumps earlier this year. The Colleague pumps had battery problems, while the Syndeo pumps had a code issue which caused the pump to stop infusing and send an alarm as well as a problem with the power button.
The company said it remains in discussions with the FDA over the matter.
"We are committed to working with the agency and our customers to resolve these issues as quickly as possible," Robert Parkinson, chairman and chief executive officer.
The company, which in July took an after-tax second-quarter charge of $65 million, or 10 cents per share, related to remediation plans associated with Colleague, did not point to any additional charges.
A company spokeswoman said it can't speculate on the reason for the FDA's seizure.
The FDA earlier this year deemed two Colleague recalls, issued voluntarily by the company, to be Class I, the most serious type.
Shares of Baxter fell $1.12 to $36.99 on the New York Stock Exchange in early trade Thursday.
Source: REUTERS
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