Device recall
Z-1646-2019: Maquet Getinge: (1) Material: 701053941R01 BEQ-TOP 9005 3/8 Custom Pk w/RF32 &…
FDA device recall · Class II · Maquet Cardiovascular, LLC
Key facts
| Recall number (Z-number) | Z-1646-2019 |
|---|---|
| Recall event | 82703 |
| Product | Maquet Getinge: (1) Material: 701053941R01 BEQ-TOP 9005 3/8 Custom Pk w/RF32 & HMOD (2) Material: 701053941R02- BEQ-TOP 9005 3/8 Custom Pk w RF32 & HMOD Material: |
| 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