Device product
AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
Z-1577-2018
Product summary
- Firm
- Vyaire Medical
- Event
- Event 78412
- Status
- Terminated
- Classification
- Class I
- Quantity
- 797 units
- Official record key
device-enforcement:Z-1577-2018
Official wording
Reason: The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
Code information: Part Number: 7730ALS. Lots: 0000993426, 0000994766, 0000996685, 0001011762, 0001011763, 0001017478, 0001026192, 0001026868, 0001028306, 0001031760, 0001032932, 0001048406, 0001082823
Distribution pattern: Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.
Derived failure modes
-
Unknown
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.