Device recall
Z-1718-2020: Endocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISION is…
FDA device recall · Class II · Boddingtons Plastics Ltd
Key facts
| Recall number (Z-number) | Z-1718-2020 |
|---|---|
| Recall event | 85214 |
| Product | Endocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISION is a device attached to the distal end of a colonoscope, designed to maintain and maximize the viewable mucosa during endocosopic therapy by manipulating colonic folds |
| Product code | FED |
| Recalling firm | Boddingtons Plastics Ltd |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 10, 2022 |
| 510(k) numbers | K151801 |
| FEI number | 3009837469 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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