Device recall
Z-0405-2024: with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093…
FDA device recall · Class II · Breas Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0405-2024 |
|---|---|
| Recall event | 93331 |
| Product | with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. intended for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system. |
| Product code | NOU |
| Recalling firm | Breas Medical, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K193586, K233452 |
| FEI number | 3010817335 |
At a glance
- 1–9 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