Device recall
Z-2592-2023: Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane…
FDA device recall · Class II · SenTec AG
Key facts
| Recall number (Z-number) | Z-2592-2023 |
|---|---|
| Recall event | 92833 |
| Product | Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDMS). |
| Product code | LKD |
| Recalling firm | SenTec AG |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K041548, K101690, K151329 |
| FEI number | 3004149774 |
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