Device recall
Z-0826-2017: Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion…
FDA device recall · Class II · Medtronic Inc
Key facts
| Recall number (Z-number) | Z-0826-2017 |
|---|---|
| Recall event | 75795 |
| Product | Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion Tubing Packs The Affinity Fusion Oxygenator with Integrated Arterial Filter with or without the Cardiotomy/Venous Reservoir with Balance1 Biosurface is intended for use in an… |
| Product code | DTZ |
| Recalling firm | Medtronic Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 1, 2017 |
| 510(k) numbers | K132972, K142784 |
| FEI number | 3001504994 |
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