Device recall
Z-1549-2018: AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector…
FDA device recall · Class I · Vyaire Medical
Key facts
| Recall number (Z-number) | Z-1549-2018 |
|---|---|
| Recall event | 78412 |
| Product | AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, manometer 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. |
| Product code | OEV |
| Recalling firm | Vyaire Medical |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 9, 2019 |
| FEI number | 2050001 |
At a glance
- None Linked 510(k)s
- 10–99 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database