BEUDAMED
    FDA Enforcement Class II Terminated

    O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography.

    Recall: Z-2830-2018 · Reported August 22, 2018

    Enforcement

    Recall Number
    Z-2830-2018
    Event ID
    80558
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beekley Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 22, 2018
    Initiation Date
    June 13, 2018
    Classification Date
    August 16, 2018
    Termination Date
    November 13, 2018
    Address
    1 Prestige Ln, Bristol, CT, 06010-7468, United States

    Description

    O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography.

    Reason

    There is a potential for imaging artifact to mimic calcifications on patient's mammograms

    Code Info

    REF 791 - Lot Numbers: 05311802 03051802 03271802 04191801 04031801 04241801 04231801 03291802 04021801 02271801 05291802 03081801 03091801 05111801 05251801 04091801 02201801 02231801 02071801 02091801 03161802 03231801 02131801 05031801 03011801 03291801 04301801 05171801 04161801 04261801 02051801 04051801 03201801 03221801 02151801 03221802 02021801 05231802 05021801 04191802 05291801 04301802 05211802 02191802 REF 791S - Lot Numbers: 03191801 02221802

    Distribution

    Worldwide Distribution: US (Nationwide) and countries of; AUSTRALIA, AUSTRIA, BAHRAIN, CANADA, GREAT BRITAIN, ISRAEL, SAUDI ARABIA, SOUTH AFRICA & UNITED ARAB EMIRATES.

    Quantity

    3,384,024 pieces in total.