Device recall
Z-2553-2018: AirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric…
FDA device recall · Class I · Vyaire Medical
Key facts
| Recall number (Z-number) | Z-2553-2018 |
|---|---|
| Recall event | 80500 |
| Product | AirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric, with mask, 28" large bore tubing, pressure-relief valve, Part Number 2K8018; b. Pediatric, with mask, 40" oxygen reservoir bag, pressure-relief valve, Part Number 2K8008; c. Pediatric, Resuscitation kit with neonatal… |
| 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