Device recall
Z-0488-2024: vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with…
FDA device recall · Class II · Vyaire Medical
Key facts
| Recall number (Z-number) | Z-0488-2024 |
|---|---|
| Recall event | 93332 |
| Product | vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV) |
| Product code | LSZ |
| Recalling firm | Vyaire Medical |
| Recall class | Class II |
| Status | Completed |
| PMA numbers | P890057 |
| FEI number | 3013421741 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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