Device recall
Z-2005-2008: Medtronic Trillium AFFINITY NT, 511T, Hollow Fiber Oxygenator with Trillium…
FDA device recall · Class II · Medtronic International Trade Inc
Key facts
| Recall number (Z-number) | Z-2005-2008 |
|---|---|
| Recall event | 48101 |
| Product | Medtronic Trillium AFFINITY NT, 511T, Hollow Fiber Oxygenator with Trillium Biopassive Surface, with Plasma Resistant Fiber. MODEL Numbers: 95215, 95216, 95217, 95249, 95250, 95252, 0H46R28, 0M81R41, 0R35R13, 0Y95R22, 1702R51, 1A11R16, 1A19R26, 1B22R5, 1F66R12, 1G47R4, 1K86R3, 1K93R5, 1L71R20… |
| Product code | DRY |
| Recalling firm | Medtronic International Trade Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 1, 2008 |
| FEI number | 1000116158 |
At a glance
- None 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