BEUDAMED
    FDA Enforcement Class II Completed

    WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, Visistat is indicated for the external skin closure of lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic, cardiovascular, urological, and plastic surgical procedures

    Recall: Z-2108-2017 · Reported May 24, 2017

    Enforcement

    Recall Number
    Z-2108-2017
    Event ID
    77102
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 24, 2017
    Initiation Date
    March 24, 2017
    Classification Date
    May 17, 2017
    Address
    2917 Weck Dr, Research Triangle Park, NC, 27709-0186, United States

    Description

    WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, Visistat is indicated for the external skin closure of lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic, cardiovascular, urological, and plastic surgical procedures

    Reason

    Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device.

    Code Info

    73H1600207

    Distribution

    Worldwide Distribution - US including CA, FL, GA, IL, IN, KS, KY, ME, MD, MA, MI, NJ, NY, NC, OH, OR, RI, TX, UT, VA, and Internationally to Australia, Belgium and France

    Quantity

    3594 eaches