Device product
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor, monometer 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-1559-2018
Product summary
- Firm
- Vyaire Medical
- Event
- Event 78412
- Status
- Terminated
- Classification
- Class I
- Quantity
- 8,124 units
- Official record key
device-enforcement:Z-1559-2018
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: 2K8010. Lot: 0001007295, 0001015414, 0001018697, 0001022519, 0001022518, 0001034530, 0001040652, 0001040653, 0001043846, 0001043847, 0001044102, 0001064454, 0001067498
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.