The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning Ventlab Resuscitator Bags, manufactured from Ventlab, LLC.
The manufacturer has initiated a voluntary medical device removal of a limited number of Ventlab Resuscitator Bags after becoming aware of complaints regarding a sticking duckbill valve that resulted in the resuscitation bags delivering no air through the patient valve, to the patient. The valves may stick due to incomplete curing during the manufacturing process. Resuscitation bags affected may not function properly and may result in a delay of treatment and life threatening health consequences that include hypoxia and hypoventilation.
There has been one report of injury requiring medical intervention due to the lack of a functional resuscitation bag and 31 reports of a delay in oxygenation due to the requirement to utilize a 2nd or 3rd device.
The manufacturer advises users to stop using the affected products and return these products to the manufacturer.
For details, please refer to the FDA websites:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm397749.htm
http://www.fda.gov/Safety/Recalls/ucm397682.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 May 2014