FDA recalls anesthesia breathing circuits
The FDA has classified the Hudson RCI Pediatric Anesthesia Breathing Circuits by Teleflex as a Class I recall, according to a press release.
The ends of the devices may crack or break before or during use, according to the release, which could cause delayed patient treatment, breathing difficulties or death if not replaced immediately.
The devices were manufactured between March 2013 and July 2014 and were distributed between June 2013 and May 2014.
On Sept. 8, 2014, Teleflex Medical sent customers an urgent medical device recall letter that explained the above issues and suggested they stop using the devices, remove them from inventory and stop distribution, and notify any customers who may have obtained the device via redistribution.
The FDA encourages health care professionals and patients to report adverse events or side effects from use of these products to the MedWatch Safety and Information and Adverse Reporting Program.