Device recall
Z-0642-2021: STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY…
FDA device recall · Class II · GA HEALTH COMPANY LIMITED
Key facts
| Recall number (Z-number) | Z-0642-2021 |
|---|---|
| Recall event | 86763 |
| Product | STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10232 |
| Product code | OCX |
| Recalling firm | GA HEALTH COMPANY LIMITED |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 3, 2021 |
| 510(k) numbers | K181509, K182998 |
| FEI number | 3014749926 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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