Device recall
Z-2156-2019: SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for…
FDA device recall · Class II · SenTec AG
Key facts
| Recall number (Z-number) | Z-2156-2019 |
|---|---|
| Recall event | 83115 |
| Product | SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and… |
| Product code | LKD |
| Recalling firm | SenTec AG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 16, 2020 |
| 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