FDA Device recall Z-1572-2018
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, PEEP valve Product Usage: The AirLife R…
- FDA Device
- Class I
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class I recall of AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, PEEP valve Product Usage: The AirLife R… by Vyaire Medical, citing 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/una….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1572-2018 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-04-27 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Vyaire Medical |
| Distribution | US |
Product
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, PEEP 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.
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.
Identifiers
| code_info | Part Number: 2K8037. Lots: 0001002934, 0001007292 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1572-2018%22
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