BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1787-2014 · Initiated June 19, 2013

    Recall

    Recall Number
    Z-1787-2014
    Event Number
    65483
    Firm
    Beekley Corporation
    FEI Number
    3000204334
    Product Code
    MUE
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    June 19, 2013
    Posted
    June 13, 2014
    Terminated
    June 16, 2014
    Address
    1 Prestige Ln, Bristol, CT, 06010-7468

    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

    Action

    Beekley sent an Urgent Medical Device Recall letters dated June 19, 2013 via FedEx with signature and tracking confirmation. The letter identified the affected product, problem and actions to be taken. Firm requests users to examine inventory, remove and return recalled product. For questions contact Chelsea Fuller, Regulatory Manager at 1-800-233-5539 x 491

    Distribution

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

    Quantity

    81 boxes