Device recall
Z-0437-2019: QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO…
FDA device recall · Class I · Maquet Cardiovascular Us Sales, Llc
Key facts
| Recall number (Z-number) | Z-0437-2019 |
|---|---|
| Recall event | 81382 |
| Product | QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055207 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. |
| Product code | DTZ |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jun 5, 2020 |
| 510(k) numbers | K102464, K141432 |
| 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