BEUDAMED
    FDA Enforcement Class II Ongoing

    KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)

    Recall: Z-0307-2024 · Reported November 22, 2023

    Enforcement

    Recall Number
    Z-0307-2024
    Event ID
    93267
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Microbiologics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 22, 2023
    Initiation Date
    October 18, 2023
    Classification Date
    November 15, 2023
    Address
    200 Cooper Ave N, N/A, Saint Cloud, MN, 56303-4440, United States

    Description

    KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)

    Reason

    A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.

    Code Info

    a) UDI/DI 20845357019169, Lot Numbers: 794-142-2, 794-142-4 b) UDI/DI 30845357019173, Lot Numbers: 794-142-3

    Distribution

    Worldwide distribution - US Nationwide and the countries of Italy, France, Turkey, Peru, Mexico.

    Quantity

    13 units