Device recall
Z-0986-2019: Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp…
FDA device recall · Class I · Maquet Cardiovascular Us Sales, Llc
Key facts
| Recall number (Z-number) | Z-0986-2019 |
|---|---|
| Recall event | 82265 |
| Product | Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails. |
| Product code | DTQ |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 14, 2020 |
| 510(k) numbers | K102726 |
| FEI number | 3008355164 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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