BEUDAMED
    FDA Enforcement Class III Terminated

    KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)

    Recall: Z-0581-2022 · Reported February 16, 2022

    Enforcement

    Recall Number
    Z-0581-2022
    Event ID
    89386
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Microbiologics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 16, 2022
    Initiation Date
    October 8, 2020
    Classification Date
    February 8, 2022
    Termination Date
    July 7, 2022
    Address
    200 Cooper Ave N, N/A, Saint Cloud, MN, 56303-4440, United States

    Description

    KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)

    Reason

    The incorrect lot number was printed on the foil pouch that the KWIK-STIK" is placed in. All foil pouches for lot 318-234-4 have the lot number misprinted as 218-234-4. The correct lot number was printed on the KWIK-STIK" canister label and KWIK-STIK" device label.

    Code Info

    Catalog Number : 0318P, Lot Number: 318-234-4, UDI: 20845357006213

    Distribution

    US distribution to . International distribution to Austria, Botswana, Brazil, Canada, China, Colombia, Finland, France, Germany, Guatemala, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Lithuania, Malaysia, Mauritius, Netherlands, Norway, Oman, Peru, Poland, Romania, South Africa, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Vietnam

    Quantity

    187 units