Device recall
Z-1196-2021: Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). The Affinity Pixie…
FDA device recall · Class I · Medtronic Perfusion Systems
Key facts
| Recall number (Z-number) | Z-1196-2021 |
|---|---|
| Recall event | 87271 |
| Product | Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with… |
| Product code | DTN |
| Recalling firm | Medtronic Perfusion Systems |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Apr 26, 2024 |
| 510(k) numbers | K183511 |
| FEI number | 1000116158 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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