Device recall
Z-0815-04: Medtronic Trillium Affinity NT Integrated-CVR Membrance Oxygenator and…
FDA device recall · Class III · Medtronic Perfusion Systems
Key facts
| Recall number (Z-number) | Z-0815-04 |
|---|---|
| Recall event | 28638 |
| Product | Medtronic Trillium Affinity NT Integrated-CVR Membrance Oxygenator and Cardiotomy Venous Reservoir with Trillium Biopassive Surface (on the oxygenator), Model 541T-R |
| Product code | DTZ |
| Recalling firm | Medtronic Perfusion Systems |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 23, 2005 |
| 510(k) numbers | K936003, K973760 |
| FEI number | 1000116158 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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