said regulators seized about 6,000 Colleague infusion pumps and roughly 850 Syndeo PCA syringe pumps that the company had withheld from shipping earlier this year.
The Food and Drug Administration took the pumps from two facilities in northern Illinois. Baxter said in July that the FDA was classifying a March product notice on the Colleague as a Class I recall, its most serious classification.
Three deaths and six serious injuries may have been associated with the device, the company said.
Baxter alerted customers in March of issues with certain models that could disrupt infusions of intravenous therapies. The company also said it was addressing a design issue with the Colleague.
Around 250,000 Colleague pumps are in use worldwide, including more than 200,000 in the U.S. About 5,000 Syndeo pumps are being used. The FDA seizure affected Baxter-owned inventory, not customer-owned pumps currently being serviced.