BEUDAMED
    FDA Enforcement Class II Terminated

    Beekley O-Spots Floral Skin Markers -Order Number: 752 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern

    Recall: Z-2111-2012 · Reported August 8, 2012

    Enforcement

    Recall Number
    Z-2111-2012
    Event ID
    62526
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beekley Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 8, 2012
    Initiation Date
    July 9, 2012
    Classification Date
    July 30, 2012
    Termination Date
    July 9, 2013
    Address
    1 Prestige Ln, N/A, Bristol, CT, 06010-7468, United States

    Description

    Beekley O-Spots Floral Skin Markers -Order Number: 752 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern

    Reason

    Digital Skin Mammography Marker separating from the backing of the spot material

    Code Info

    Lot Numbers: A036, A037, A038, A039, A040, A041, A042, A044, A045, A046

    Distribution

    US Nationwide Distribution

    Quantity

    267,332 units