Device recall
Z-1661-2023: Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model…
FDA device recall · Class II · Maquet Medical Systems USA
Key facts
| Recall number (Z-number) | Z-1661-2023 |
|---|---|
| Recall event | 92006 |
| Product | Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445 |
| Product code | DTZ |
| Recalling firm | Maquet Medical Systems USA |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K102919 |
| FEI number | 3008355164 |
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