Device recall
Z-2552-2018: AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with…
FDA device recall · Class I · Vyaire Medical
Key facts
| Recall number (Z-number) | Z-2552-2018 |
|---|---|
| Recall event | 80500 |
| Product | AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with mask, oxygen reservoir bag, Part Number 2K8004; b. Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve, Part Number 2K8035C2; c. Adult, with mask, 28" large bore tubing, Part Number 2K8017; d. Adult, with mask… |
| Product code | BTM |
| Recalling firm | Vyaire Medical |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jul 7, 2020 |
| FEI number | 2050001 |
At a glance
- None Linked 510(k)s
- 1–9 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