Vyaire Medical is recalling the AirLife Resuscitation Device & Broselow Convenience Kit due to an error in its product design that may result in difficultly or the inability to disconnect the mask from the elbow of the resuscitator, according to an FDA MedWatch Alert.
The Vyaire Medical AirLife Resuscitation Device & Broselow Convenience Kit are manual resuscitation devices used together as one pair to provide constant ventilation to adults and children who are not breathing or cannot adequately breathe on their own following placement of an advanced airway device (tracheal or tracheostomy tube). The products are used in hospitals and other acute health care settings.
The AirLife Resuscitation Device & Broselow Convenience Kit comes fully assembled and ready to use with a cushioned mask, which can be removed to provide continuous ventilation after placement of an advanced airway device. However, the cushioned mask component has the possibility of sticking to the elbow of the resuscitator, making removal of the mask difficult, or unattainable. Difficulty disconnecting the mask from the resuscitator could result in a delay in or inability to provide necessary ventilation to the patient and potentially result in serious patient injury, such as hypoxia (inadequate oxygen supply), or death.
Model/Item Numbers: See “Full List of Affected Devices”
Lot Numbers: See “Full List of Affected Devices“