Device recall
Z-0677-2020: Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane…
FDA device recall · Class II · GETINGE US SALES LLC
Key facts
| Recall number (Z-number) | Z-0677-2020 |
|---|---|
| Recall event | 84352 |
| Product | Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000 |
| Product code | DTZ |
| Recalling firm | GETINGE US SALES LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K100278 |
| FEI number | 3012092534 |
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