Device recall
Z-2105-2018: Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special…
FDA device recall · Class III · Datascope Corporation
Key facts
| Recall number (Z-number) | Z-2105-2018 |
|---|---|
| Recall event | 80086 |
| Product | Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490 |
| Product code | DWE |
| Recalling firm | Datascope Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 7, 2019 |
| 510(k) numbers | K080592 |
| FEI number | 1000222374 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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