BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0307-2024 · Initiated October 18, 2023

    Recall

    Recall Number
    Z-0307-2024
    Event Number
    93267
    Firm
    Microbiologics Inc
    FEI Number
    2150138
    Product Code
    JTR
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    October 18, 2023
    Posted
    November 15, 2023
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440

    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.

    Action

    Microbiologics issued an Urgent Medical Device Recall notice to its consignees on 10/18/2023 via email. The notice explained the issue and requested that the labs review their procedures to understand who the issue affects its usage, use or discard depending on its procedures, and contact Microbiologics if a replacement kit is needed. For questions or concerns contact the Recall Support team at 1.320.229.7073 or [email protected].

    Distribution

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

    Quantity

    13 units