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FDAFDA · Food and drugs·Recall number Z-1718-2020

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

Published April 22, 2020 · Recall initiated: March 11, 2020

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · E-Mail

Recall details

Manufacturer
Boddingtons Plastics Ltd
Distributor
Nationwide Foreign:
Lot
All batches distributed prior to 1st May 2020.
Risk classification
Class II
Area (FDA)
device
Country
United Kingdom

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