Teleflex (NYSE:TFX) said it issued a Class 1 recall of more than 27,000 pediatric anesthesia breathing circuits over concerns that components of the devices could crack during use, resulting in respiratory distress or even death.
The FDA classified the pullback of Teleflex’s Hudson RCI pediatric anesthesia breathing circuits as a Class I recall, used "when it is likely that use of these devices will cause serious health problems or death."
Teleflex sent a letter to clients Sept. 8 advising that the devices immediately be taken out of service. The letter also urged clients to notify any parties who may have received the devices through re-distribution, the FDA added.
In a statement issued Oct. 3, Teleflex said there had been 24 complaints that the ends of the pediatric breathing circuits could crack before or during use. It added that no deaths or injuries had been reported.