Dexter, MI, US · 2 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| BYS | Oxygenator, Long Term Support Greater Than 6 Hours | Class II | Cardiovascular | 1 | 2023-10-04 |
| PZS | Dual Lumen Ecmo Cannula | Class II | Cardiovascular | 1 | 2021-05-03 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2023-10-11 | Class II | Ongoing | Z-1310-2024 | NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, … | — | May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance during use. The reduction of water flow and r… |
| 2023-10-11 | Class II | Ongoing | Z-1309-2024 | NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, re… | — | May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance during use. The reduction of water flow and r… |