Recall Z-1718-2020 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
Boddingtons Plastics Ltd
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
| Date | Mar 11, 2020 |
| Status | Terminated |
| Reason | Updated Instructions For Use- to contraindications and potential complications/adverse events of the colonoscopy procedure (without using Endocuff Vision Device) |
| Root cause | Other |
| Action | Boddingtons issued Medical Device Correction Notice dated 3/13/20 to the Distributor stating reason for correction and take the following actions: It is not necessary to return any Endocuff Vision you have in stock, as this recall affects the IFU and not the device. It can continue to be used, provided users are aware of the updated information in the IFU. Healthcare letters dated 3/2/620 was distributed There is no requirement to replace existing stock. New stock with the updated IFU will become available in May 2020. Ensure relevant staff members are informed of this recall, including loc |
| Quantity | 13202 Units US |
| Distribution | Nationwide Foreign: |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151801 | Arc Endocuff Vision Boddingtons Plastics, Ltd., Aug 13, 2015 |