Device recall
Z-1657-2023: QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item…
FDA device recall · Class II · Maquet Medical Systems USA
Key facts
| Recall number (Z-number) | Z-1657-2023 |
|---|---|
| Recall event | 92006 |
| Product | QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-HMO 50000-USA 701067905 HMO 50000-USA 701067891 HMO 51000-USA 701067895 |
| Product code | DTZ |
| Recalling firm | Maquet Medical Systems USA |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K090689 |
| 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