Device recall
Z-0476-2008: Medtronic Trillium Affinity NT, 541T, Integrated CVR/Membrane Oxygenator (Plasma…
FDA device recall · Class III · Medtronic Perfusion Systems
Key facts
| Recall number (Z-number) | Z-0476-2008 |
|---|---|
| Recall event | 45485 |
| Product | Medtronic Trillium Affinity NT, 541T, Integrated CVR/Membrane Oxygenator (Plasma Resistant Fiber [PRF] Medtronic, Inc., Minneapolis, MN 55432-5604. |
| Product code | DTZ |
| Recalling firm | Medtronic Perfusion Systems |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 23, 2008 |
| 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