The United States Food and Drug Administration (FDA) has issued a medical device safety alert, concerning various presource kits containing a pre-assembled anesthesia circuit, manufactured by Cardinal Health.
Cardinal Health discovered that various Presource Kits containing a pre-assembled anesthesia circuit and filter may contain outer plastic packaging on one or more components. If the packaging is removed without dissembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction in airflow. This may result in serious adverse health consequences including low blood oxygen (hypoxia), suffocation and death.
According to the FDA, Cardinal Health has notified customers of the problem and products affected on 26 March 2013 and advised customers to examine their inventories, identify and locate the products affected, notify clinicians, and affix a warning label on the front of each kit. The warning label instructs clinicians to remove and discard the anesthesia circuit and filter assembly.
For details, please visit the following FDA websites:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm351024.htm
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm350996.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 08 May 2013