BEUDAMED
    FDA Enforcement Class II Terminated

    The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t

    Recall: Z-2543-2021 · Reported October 6, 2021

    Enforcement

    Recall Number
    Z-2543-2021
    Event ID
    88278
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vascutek, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 6, 2021
    Initiation Date
    July 8, 2021
    Classification Date
    September 24, 2021
    Termination Date
    August 19, 2024
    Address
    Newmains Avenue, N/A, Inchinnan, N/A, N/A, United Kingdom

    Description

    The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t

    Reason

    The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.

    Code Info

    To be reported.

    Distribution

    Distribution was made to PR and Guam.

    Quantity

    159 total vascular grafts and patches