Baxter (NYSE:BAX) has issued an urgent device correction involving hundreds of thousands of Sigma Spectrum infusion pumps in which it warns that improper cleaning could cause corrosion around the batteries.
So far, Baxter has received 16 reports of serious injuries related to the problem. FDA has labeled the recall as Class I, its most serious level. FDA said the recall involved 306,617 units of the Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 8).
“I’d like to emphasize that this is not a new issue. We alerted customers and FDA to the risks related to improper cleaning of the pumps months ago, and are working on updating the Instructions for Use to provide additional information,” Baxter spokesperson Bess Featherstone told Drug Delivery Business News and MassDevice.