Device recall
Z-2178-2018: Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part…
FDA device recall · Class II · Datascope Corporation
Key facts
| Recall number (Z-number) | Z-2178-2018 |
|---|---|
| Recall event | 80081 |
| Product | Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and… |
| Product code | DWE |
| Recalling firm | Datascope Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 7, 2020 |
| 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