CareFusion Airlife Infant Breathing Circuit: Class I Recall - Potential for Leak in Closed Ventilation System
MedSun: Newsletter #75, August 2012
FDA MedWatch Safety Alert
FDA notified healthcare professionals of the Class I recall of the Airlife infant breathing circuit due to the risk that the Y-adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient. These products may cause serious adverse health consequences, including death. The recalled products were distributed from July 1, 2010 through May 7, 2012. See the Recall Notice for a listing of affected lot numbers.
FDA MedWatch Safety Alert. CareFusion Airlife Infant Breathing Circuit: Class I Recall - Potential for Leak in Closed Ventilation System. July 6, 2012.