BEUDAMED
    FDA Recall 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 · Initiated July 9, 2012

    Recall

    Recall Number
    Z-2111-2012
    Event Number
    62526
    Firm
    Beekley Corporation
    FEI Number
    3000204334
    Product Code
    JAC
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    July 9, 2012
    Posted
    July 31, 2012
    Terminated
    July 9, 2013
    Address
    1 Prestige Ln, Bristol, CT, 06010-7468

    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

    Action

    Beekley Medical issued an Urgent Medical Device Recall letter dated July 9, 2012 to all affected customers. The letter identified the affected products, problem and actions to be taken. Customers were advised to contact Beekley Medical's Customer Service Team at 1-800-233-5539 to return affected lots for replacement. Customers were instructed to complete and return the attached reply form.

    Distribution

    US Nationwide Distribution

    Quantity

    267,332 units