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[Recalled] 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 manipula

recall fda device united-kingdom

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductEndocuff 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
Brand / manufacturerBoddingtons Plastics Ltd
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-1718-2020
Country of noticeUnited Kingdom
Risk levelClass II
Hazard typerecall
Notice date11 March 2020

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Updated Instructions For Use- to contraindications and potential complications/adverse events of the colonoscopy procedure (without using Endocuff Vision Device)

This Class II recall concerns device products distributed in United Kingdom and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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