Device recall
Z-1548-2021: Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat…
FDA device recall · Class II · Atos Medical AB
Key facts
| Recall number (Z-number) | Z-1548-2021 |
|---|---|
| Recall event | 87635 |
| Product | Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma. |
| Product code | BYD |
| Recalling firm | Atos Medical AB |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 17, 2022 |
| FEI number | 3002806269 |
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