The United States Food and Drug Administration (FDA) issued a medical device safety alert concerning Hudson RCI Pediatric Anaesthesia Breathing Circuits, manufactured by Teleflex Medical. The affected products were manufactured from March 2013 to July 2014 and distributed from June 2013 to May 2014.
According to the FDA, 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.
On September 8, 2014, the manufacturer sent customers an Urgent Medical Device Recall letter explaining the device problem and actions to be taken. The manufacturer recommends the following actions:-
For details, please refer to the following FDA websites:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm417868.htm
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm417731.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 8 October 2014