BEUDAMED
    FDA Enforcement Class II Terminated

    Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.

    Recall: Z-1912-2015 · Reported July 8, 2015

    Enforcement

    Recall Number
    Z-1912-2015
    Event ID
    71305
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vascutek, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 8, 2015
    Initiation Date
    May 15, 2015
    Classification Date
    June 26, 2015
    Termination Date
    October 20, 2015
    Address
    Newmains Avenue, Inchinnan, N/A, United Kingdom

    Description

    Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.

    Reason

    Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.

    Code Info

    Product Code 431508, Batch 301509/01, Serial Numbers 0001515180, 0001515181, 0001515182, 0001515183, 0001515184, 0001515185, 0001515186, 0001515187, 0001515188, 0001515189, 0001515190, 0001515191

    Distribution

    Distributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany.

    Quantity

    12