Boddingtons Plastics Ltd Wheelbarrow Park Estate Pattenden Lane Tonbridge United Kingdom 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 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Updated Instructions For Use- to contraindications and potential complications/adverse events of the colonoscopy procedure (without using Endocuff Vision Device)

Recommended Action

Per FDA guidance

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 locums, biomedical engineers, operating theatre staff and relevant clinicians who may decide to monitor for adverse events, as applicable. If you have supplied or transferred any potentially affected product to another facility or organisation, let that facility know of the recall immediately by providing a copy of this letter. Please complete the attached acknowledgement form immediately even if you do not have any affected stock and return it to mdr@boddingtons.co.uk or fax to 004401622833701 to enable Boddingtons to reconcile this process.