BEUDAMED
    FDA Recall Terminated

    QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200

    Recall: Z-0211-2022 · Initiated September 22, 2021

    Recall

    Recall Number
    Z-0211-2022
    Event Number
    88818
    Firm
    Z-Medica, LLC
    FEI Number
    3004138549
    Product Code
    FRO
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    September 22, 2021
    Terminated
    June 11, 2024
    Address
    4 Fairfield Blvd, Wallingford, CT, 06492-1857

    Description

    QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200

    Reason

    Lack of Packaging seal integrity may result in a sterile barrier breach.

    Action

    Z-Medica notifed the customer via email on Wednesday 9/22/2021 and requested to place the products on hold. A formal notification letter was sent to the customer on 9/23/2021. Letter states reason for recall, health risk and action to take: We are requesting that you return all units of lot 12645 to Z-Medica, LLC ( 4 Fairfield Boulevard, Wallingford, CT 06492, ATTN: Recall - Regulatory Affairs). Please and return the attached Acknowledgement Form via email to [email protected]. If you have distributed any units of this lot number, please contact your customers and arrange for return of these units from lot 12645. Should you have any questions about this information please contact me at (203) 774-5686 or by email at [email protected]. issued Urgent Medical Device Recall letter

    Distribution

    US Nationwide distribution in the state of NC.

    Quantity

    2400 units