FDA Classifies Teleflex Device Recall as Class I

The U.S. Food and Drug Administration (FDA) has classified Teleflex Inc.’s voluntary medical device recall of Hudson RCI pediatric anesthesia breathing circuits as a class 1 recall. The agency defines a class I recall as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

Telefex recalled the devices due to complaints that the ends of the pediatric breathing circuits can crack prior to and during use. If the circuits crack during use, there will be a need for immediate replacement of the device, and possible respiratory distress to the patient.

Teleflex notified both domestic and foreign hospitals and distributors via an urgent medical device recall letter dated September 10, 2014. This recall involves the retrieval of unused product in the field.

At this time, there have been 24 complaints of this issue. There have been no reports of patient injury as a result of this issue. Six product codes more than 30 lots are affected by this recall for a total of 27,176 units distributed to the field.

Teleflex makes critical care and surgical devices, and is based in Wayne, Pa.