Device recall
Z-1194-2021: Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 1/B). The…
FDA device recall · Class I · Medtronic Perfusion Systems
Key facts
| Recall number (Z-number) | Z-1194-2021 |
|---|---|
| Recall event | 87271 |
| Product | Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 1/B). 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… |
| 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