Device recall
Z-1513-2019: Maquet Getinge-BO-TOP 26300 CUSTOM PACK Material: 701050975
FDA device recall · Class II · Maquet Cardiovascular, LLC
Key facts
| Recall number (Z-number) | Z-1513-2019 |
|---|---|
| Recall event | 82703 |
| Product | Maquet Getinge-BO-TOP 26300 CUSTOM PACK Material: 701050975 |
| 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