Baxter: FDA Seizes Recalled Drug PumpsOct 13, 2005 | Business Week
Baxter Healthcare Corp. said Thursday that the Food and Drug Administration seized infusion pumps the medical device maker held at two facilities in Illinois following a recent recall of the products.
The company said about 6,000 Colleague infusion pumps and 850 Syndeo syringe pumps were seized at the facilities. The devices, which deliver controlled amounts of intravenous drugs to patients, were recalled in September after battery problems were linked to four deaths and 10 serious injuries. The seized products had been put on hold by Baxter after the FDA classified the recall as a Class I -- the most serious type -- an action taken when defective products pose a life-threatening risk.
Baxter said it was unable to provide to customers with replacement pumps that have been removed from service. The company continues to work with the FDA on corrective actions concerning the devices. The recall does not affect pumps currently being serviced by Baxter.
About 250,000 Colleague pumps are in use worldwide, with more than 80 percent in the United States. Worldwide, there are about 5,000 Syndeo pumps in use.