Device recall
Z-0531-2015: The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda…
FDA device recall · Class II · Medtronic Perfusion Systems
Key facts
| Recall number (Z-number) | Z-0531-2015 |
|---|---|
| Recall event | 69746 |
| Product | The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a single-use, microporous, hollow-fiber, gas-exchange device with plasma resistant fiber and integrated heat exchanger and arterial filter. The oxygenator is bonded on its primary blood contacting… |
| Product code | DTZ |
| Recalling firm | Medtronic Perfusion Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 11, 2015 |
| 510(k) numbers | K123314, K132972 |
| 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