BEUDAMED
    FDA Recall 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 · Initiated March 24, 2017

    Recall

    Recall Number
    Z-2108-2017
    Event Number
    77102
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    GDT
    Status
    Completed
    Root Cause
    Error in labeling
    Initiated
    March 24, 2017
    Address
    2917 Weck Dr, Research Triangle Park, NC, 27709-0186

    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.

    Action

    Teleflex sent an Urgent Medical Device Correction Notice dated March 24, 2017, to consignees. The letter requested that they check inventory on hand and quarantine product for return. They letter also requested that distributors conduct a sub-recall. The letter included a reply form to be returned. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990.

    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