Boddingtons Plastics Ltd recalls Endocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISION is a device attached to the distal end of…

Recall date

March 11, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1718-2020

FDA classification

Class II

Brand / firm

Boddingtons Plastics Ltd

Sold / distributed

Nationwide Foreign:

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was 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 manipulating colonic folds