Baxter says FDA seizes nearly 7,000 pumps

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.