BEUDAMED
    FDA Recall Terminated

    HARDY DIAGNOSTICS CatScreen, 25dsk/vial

    Recall: Z-0554-2022 · Initiated December 1, 2021

    Recall

    Recall Number
    Z-0554-2022
    Event Number
    89151
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    JTO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 1, 2021
    Terminated
    January 9, 2023
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    HARDY DIAGNOSTICS CatScreen, 25dsk/vial

    Reason

    Product stored incorrectly in temperature controlled setting instead of refrigeration.

    Action

    Medline notified consignees on 12/01/2021, via first class mail letter titled URGENT RECALL NOTIFICATION. Customers were instructed to immediately check stock for affected product, quarantine any affected product on hand, complete and return the response form indicating product destroyed, and notify customers if the product was further distributed.

    Distribution

    US Nationwide distribution in the state of California.

    Quantity

    100 units (4 packs, 25 per pack)