BEUDAMED
    FDA Enforcement Class II Terminated

    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: Z-1718-2020 · Reported April 22, 2020

    Enforcement

    Recall Number
    Z-1718-2020
    Event ID
    85214
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boddingtons Plastics Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 22, 2020
    Initiation Date
    March 11, 2020
    Classification Date
    April 16, 2020
    Termination Date
    August 10, 2022
    Address
    Wheelbarrow Park Estate, Pattenden Lane, Tonbridge, N/A, United Kingdom

    Description

    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

    Reason

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

    Code Info

    All batches distributed prior to 1st May 2020.

    Distribution

    Nationwide Foreign:

    Quantity

    13202 Units US