BEUDAMED
    FDA Recall Terminated

    Beekley Medical 0-SPOT Mammography Skin Markers REF 652

    Recall: Z-2309-2017 · Initiated May 8, 2017

    Recall

    Recall Number
    Z-2309-2017
    Event Number
    77295
    Firm
    Beekley Corporation
    FEI Number
    3000204334
    Product Code
    JAC
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    May 8, 2017
    Terminated
    June 20, 2017
    Address
    1 Prestige Ln, Bristol, CT, 06010-7468

    Description

    Beekley Medical 0-SPOT Mammography Skin Markers REF 652

    Reason

    Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels

    Action

    Beekley Medical issued letter dated May 8, 2017 advised user of the problem and to examine inventory and return product.C Accounts requested to complete response form . Questions: Quality Assurance & Regulatory Manager at 1-800-233-5539 x 434.

    Distribution

    US Distribution to the states of : AR, CA GA, IL, TX, MN, NV, NY, WI., and Internationally to Canada.

    Quantity

    104 boxes (58/box)= 6,032 total units