October 14, 2005

The FDA has seized roughly 6,000 infusion pumps and 850 syringe pumps manufactured by Baxter Healthcare.

The seizure involved Baxter's Colleague Volumetric Infusion Pumps and Syndeo PCA Syringe Pumps, which were being held at two facilities in Illinois. Baxter had placed a voluntary hold on shipments of the products earlier this year after batter problems were discovered, the firm said.

The FDA's latest action affects only Baxter's inventory, and not the customer-owned pumps currently being serviced by Baxter, the firm said. Baxter also said it is unable to provide loaner pumps to customers who have removed pumps from service. The company, however, reiterated the fact that it has developed an aggressive corrective action plan for the products, and remains in discussions with the FDA.

Roughly 250,000 Colleague infusion pumps are in use worldwide, including more than 200,000 in the U.S., Baxter said. There are approximately 5,000 Syndeo pumps in use worldwide.

(http://www.fdanews.com/ddl target=_blank)