BEUDAMED
    FDA Enforcement Class II Terminated

    HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4

    Recall: Z-1124-2022 · Reported June 1, 2022

    Enforcement

    Recall Number
    Z-1124-2022
    Event ID
    90119
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Devicor Medical Products Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 1, 2022
    Initiation Date
    March 30, 2022
    Classification Date
    May 23, 2022
    Termination Date
    April 30, 2024
    Address
    300 E Business Way Fl 5, Cincinnati, OH, 45241-2384, United States

    Description

    HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4

    Reason

    Small patient labels do not match the primary device label. The primary device label accurately identifies the product as 4010-05-08-T4, while the smaller patient label incorrectly identifies the product as 4010-05-08-T3.

    Code Info

    UDI-DI: 00841911102472 Lot F12201281D

    Distribution

    US Nationwide distribution in the states of DE, KY, NY, OH, WV.

    Quantity

    90 devices