BEUDAMED
    FDA Enforcement Class II Terminated

    QuikClot TraumaPad, Part# 460 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-0925-2018 · Reported March 14, 2018

    Enforcement

    Recall Number
    Z-0925-2018
    Event ID
    79407
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Z-Medica, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 14, 2018
    Initiation Date
    November 17, 2017
    Classification Date
    March 8, 2018
    Termination Date
    June 4, 2018
    Address
    4 Fairfield Blvd, N/A, Wallingford, CT, 06492-1857, United States

    Description

    QuikClot TraumaPad, Part# 460 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

    A customer complained that one of the pouches in a box of 10 had "QuikClot Roll" pouch instead of "QuikClot TraumaPad" pouch. The carton as well as the remaining 9 pouches were properly identified as QuikClot Trauma Pad. The customer alleged that when the pouch was opened, it contained a QuikClot TraumaPad. All 10 pouches in the box had the correct part number, lot number, and expiration date for the prod uct (QuikClot TraumaPad).

    Code Info

    Part# 460, Lot# 7397

    Distribution

    Nationally

    Quantity

    4890