BEUDAMED
    FDA Enforcement Class II Terminated

    HARDY DIAGNOSTICS CatScreen, 25dsk/vial

    Recall: Z-0554-2022 · Reported February 9, 2022

    Enforcement

    Recall Number
    Z-0554-2022
    Event ID
    89151
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 9, 2022
    Initiation Date
    December 1, 2021
    Classification Date
    February 2, 2022
    Termination Date
    January 9, 2023
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    HARDY DIAGNOSTICS CatScreen, 25dsk/vial

    Reason

    Product stored incorrectly in temperature controlled setting instead of refrigeration.

    Code Info

    Model Number HADZ110, all lots

    Distribution

    US Nationwide distribution in the state of California.

    Quantity

    100 units (4 packs, 25 per pack)