BEUDAMED
    FDA Recall Terminated

    QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield Boulevard, Wallingford, CT 06492 USA For use as a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries

    Recall: Z-2612-2017 · Initiated May 17, 2017

    Recall

    Recall Number
    Z-2612-2017
    Event Number
    77316
    Firm
    Z-Medica, LLC
    FEI Number
    3004138549
    Product Code
    FRO
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    May 17, 2017
    Terminated
    June 15, 2018
    Address
    4 Fairfield Blvd, Wallingford, CT, 06492-1857

    Description

    QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield Boulevard, Wallingford, CT 06492 USA For use as a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries

    Reason

    Packaging breach may compromise sterility

    Action

    Z- Medica issued recall letters dated May 15, 2017, on May 17 2017, advising users of the problem and requesting customers to check their inventory and return product for replacement. Distributors requested to sub recall. Customers with questions were instructed to contact (203) 774-5686.

    Distribution

    Worldwide Distribution - US (Nationwide) Foreign: South Korea, Taiwan, Thailand

    Quantity

    2910 pieces