Device recall
Z-1310-2024: NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life…
FDA device recall · Class II · Mc3 Inc
Key facts
| Recall number (Z-number) | Z-1310-2024 |
|---|---|
| Recall event | 94016 |
| Product | NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: 48135, 48135E |
| Product code | BYS |
| Recalling firm | Mc3 Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K191935 |
| FEI number | 3011468686 |
At a glance
- 1–9 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