Device recall
Z-0645-2018: Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The…
FDA device recall · Class II · Medtronic Perfusion Systems
Key facts
| Recall number (Z-number) | Z-0645-2018 |
|---|---|
| Recall event | 79058 |
| Product | Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood is collected and de foamed while cardiotomy blood is… |
| Product code | DTN |
| Recalling firm | Medtronic Perfusion Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 21, 2020 |
| 510(k) numbers | K936003 |
| FEI number | 1000116158 |
At a glance
- 1–9 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