Device recall
Z-0491-2022: Medtronic Custom Perfusion kits, with the following product descriptions and…
FDA device recall · Class II · Medtronic Perfusion Systems
Key facts
| Recall number (Z-number) | Z-0491-2022 |
|---|---|
| Recall event | 88932 |
| Product | Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM PACK BB10Q85R FILTER (Model BB10Q85R); 2. CUSTOM PACK BB11C01R MIDI DEEP (Model BB11C01R); 3. CUSTOM PACK BB7H95R22 HYP MAIN (Model B7H95R22); 4. CUSTOM PACK BB7H95R25 HYP MAIN (Model… |
| Product code | DWF |
| Recalling firm | Medtronic Perfusion Systems |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 1000116158 |
At a glance
- None 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