Device recall
Z-1676-2019: Maquet Getinge BO-TOP 28903 Adult ECC Pack Material: -709000093R01
FDA device recall · Class II · Maquet Cardiovascular, LLC
Key facts
| Recall number (Z-number) | Z-1676-2019 |
|---|---|
| Recall event | 82703 |
| Product | Maquet Getinge BO-TOP 28903 Adult ECC Pack Material: -709000093R01 |
| Product code | DWF |
| Recalling firm | Maquet Cardiovascular, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 28, 2025 |
| 510(k) numbers | K080592 |
| FEI number | 2242352 |
At a glance
- 1–9 Linked 510(k)s
- 100–999 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