Device product
AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve 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-1565-2018
Product summary
- Firm
- Vyaire Medical
- Event
- Event 78412
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1,800 units
- Official record key
device-enforcement:Z-1565-2018
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: 2K8020. Lots: 0001002842, 0001018800, 0001018801
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.