BEUDAMED
    FDA Enforcement Class II Terminated

    Michels Transport Medium, 20ML Prefilled Cont

    Recall: Z-0656-2022 · Reported March 2, 2022

    Enforcement

    Recall Number
    Z-0656-2022
    Event ID
    89164
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 2, 2022
    Initiation Date
    December 1, 2021
    Classification Date
    February 18, 2022
    Termination Date
    February 13, 2023
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Michels Transport Medium, 20ML Prefilled Cont

    Reason

    Product stored incorrectly in temperature controlled setting instead of refrigeration.

    Code Info

    Model Number: AZSES3270, all lots with expiration date range of 08/28/2021 through 09/03/2023

    Distribution

    US Nationwide distribution in the states of Colorado, Florida, New York, North Carolina, and Texas.

    Quantity

    2,816 units (22 cases, 128 per case)