The Hudson RCI Pediatric Anesthesia Breathing Circuit was recalled because the ends of the devices may crack or break before or during use. This could cause serious health risks, including delayed patient treatment and breathing difficulties if not replaced immediately. Use of this device may also cause death.
Anesthesia circuits deliver a mixture of anesthesia and/or other gases from a mechanical ventilator to a patient. The Hudson RCI Pediatric Anesthesia Breathing Circuit made by Teleflex Medical of Durham, North Carolina, is used in hospitals to care for pediatric patients.
Affected devices were manufactured from March 2013 to July 2014.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall
See also Medical Law Perspectives, August 2012 Report: Anesthesiology Errors: Complications, Malpractice, and Catastrophe