BEUDAMED
    FDA Enforcement Class III Terminated

    KWIK-STIK" plus: Clostridium perfringens

    Recall: Z-1125-2022 · Reported June 1, 2022

    Enforcement

    Recall Number
    Z-1125-2022
    Event ID
    90150
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Microbiologics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 1, 2022
    Initiation Date
    May 6, 2022
    Classification Date
    May 23, 2022
    Termination Date
    January 16, 2024
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440, United States

    Description

    KWIK-STIK" plus: Clostridium perfringens

    Reason

    Labeling error.

    Code Info

    catalog number: 0801P; lot number: 801-44-4; expiration date: 05/31/2023; UDI: 20845357019374

    Distribution

    Distributed US Nationwide to IA, TN and internationally to Mexico, Colombia, France, South Africa, United Kingdom.

    Quantity

    8 units