BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0211-2022 · Reported November 17, 2021

    Enforcement

    Recall Number
    Z-0211-2022
    Event ID
    88818
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Z-Medica, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 17, 2021
    Initiation Date
    September 22, 2021
    Classification Date
    November 5, 2021
    Termination Date
    June 11, 2024
    Address
    4 Fairfield Blvd, N/A, Wallingford, CT, 06492-1857, United States

    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.

    Code Info

    Lot# 12645 UDI I Primary DI Number: 00841495102004

    Distribution

    US Nationwide distribution in the state of NC.

    Quantity

    2400 units