BEUDAMED
    FDA Recall Terminated

    O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography.

    Recall: Z-2830-2018 · Initiated June 13, 2018

    Recall

    Recall Number
    Z-2830-2018
    Event Number
    80558
    Firm
    Beekley Corporation
    FEI Number
    3000204334
    Product Code
    JAC
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 13, 2018
    Terminated
    November 13, 2018
    Address
    1 Prestige Ln, Bristol, CT, 06010-7468

    Description

    O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography.

    Reason

    There is a potential for imaging artifact to mimic calcifications on patient's mammograms

    Action

    On June 14, 2018, Beekley Medical issued an "URGENT MEDICAL DEVICE RECALL" notice dated June 13, 2018 to customers. The notice described the products, problem and actions to be taken. Customers are advised to do the following: - Inspect stock and quarantine affected product - complete and return the acknowledgement response form via fax to: 1-800-735-1234 or mail. - contact firm if inventory of affected product remains with customers at 1-800-233-5539 between 8:00am - 5:30pm EDT. If you have any issues occurred or for further question, contact Quality Assurance & Regulatory Manager at 1-800-233-5539x434.

    Distribution

    Worldwide Distribution: US (Nationwide) and countries of; AUSTRALIA, AUSTRIA, BAHRAIN, CANADA, GREAT BRITAIN, ISRAEL, SAUDI ARABIA, SOUTH AFRICA & UNITED ARAB EMIRATES.

    Quantity

    3,384,024 pieces in total.