BEUDAMED
    FDA Enforcement Class III Terminated

    Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Product Usage: To identify raised moles in Mammography

    Recall: Z-1787-2014 · Reported June 18, 2014

    Enforcement

    Recall Number
    Z-1787-2014
    Event ID
    65483
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beekley Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 18, 2014
    Initiation Date
    June 19, 2013
    Classification Date
    June 12, 2014
    Termination Date
    June 16, 2014
    Address
    1 Prestige Ln, N/A, Bristol, CT, 06010-7468, United States

    Description

    Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Product Usage: To identify raised moles in Mammography

    Reason

    Light Image O-Spots Dispenser mislabeled as Soft n' Stretchy Light Image S-Spots

    Code Info

    Lot Number: 252.04261301

    Distribution

    Worldwide Distribution - USA in the states of CA, FL, MA, NC, NY, and PA.

    Quantity

    81 boxes