Device recall
Z-1659-2023: QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No…
FDA device recall · Class II · Maquet Medical Systems USA
Key facts
| Recall number (Z-number) | Z-1659-2023 |
|---|---|
| Recall event | 92006 |
| Product | QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 70000-USA 701067820 HMO 71000-USA 701067823 BEQ-HMO 71000-USA 701067829 |
| Product code | DTZ |
| Recalling firm | Maquet Medical Systems USA |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K082117 |
| 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