FDA Issues Class I Recalls for Baxter, Covidien Devices

The FDA has classified Baxter International’s recent urgent device correction for its U.S. Colleague Volumetric Infusion Pumps as a Class I recall. In January, Baxter sent an urgent correction letter to its customers stating that the products could stop infusing or overheat, the company says in a statement. The malfunctioning devices are subject to a Class I recall because they put patients at risk of serious injury or death. The FDA’s notice comes on the heels of a recent Class I recall for Covidien’s pediatric tracheostomy tubes that stemmed from complaints of difficulties inserting the product into patients, the FDA says.