BEUDAMED
    FDA Enforcement Class II 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 · Reported June 28, 2017

    Enforcement

    Recall Number
    Z-2612-2017
    Event ID
    77316
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Z-Medica, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 28, 2017
    Initiation Date
    May 17, 2017
    Classification Date
    June 19, 2017
    Termination Date
    June 15, 2018
    Address
    4 Fairfield Blvd, Wallingford, CT, 06492-1857, United States

    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

    Code Info

    Lot # 7313

    Distribution

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

    Quantity

    2910 pieces