BEUDAMED
    FDA Recall Terminated

    ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Disposable Bipolar Cables,STERILE The Minor Surgery Bipolar Cable is an accessory that is used to connect the bipolar handpieces to the RF generator for electrosurgical procedures that require the bipolar waveform.

    Recall: Z-0748-2017 · Initiated September 7, 2016

    Recall

    Recall Number
    Z-0748-2017
    Event Number
    75351
    Firm
    Ellman International, Inc.
    FEI Number
    2428235
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    September 7, 2016
    Terminated
    June 18, 2018
    Address
    400 Karin Ln, Hicksville, NY, 11801-5352

    Description

    ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Disposable Bipolar Cables,STERILE The Minor Surgery Bipolar Cable is an accessory that is used to connect the bipolar handpieces to the RF generator for electrosurgical procedures that require the bipolar waveform.

    Reason

    Mislabeling of the "expiration date". The expiration date on the outer box and the individual pouches do not match. The expiration date on the box is correct with a date of 2018-02.

    Action

    Cynosure, Inc. dba Ellman distributed Urgent Medical Device Recall Notices dated September 6, 2016, and response forms to their customers via UPS overnight. Cynosure has identified an error in the Expiration Date on the label of the Minor Surgery Bipolar Cable pouch. The Expiration Date on the individual pouches that are provided in the 5 pack boxes do not match the Expiration Date on the box. The Expiration Date on the box is correct with a date of 2018-02, but the label on the individual pouches has a date of 2021-02. Actions To Be Taken - Return any cables subject to recall. You will be contacted by a Cynosure Customer Service Representative who will provide you with a RMA number for any cables that are being returned. Complete and return the response form via email to [email protected]. Cynosure will replace affected products at no charge upon receipt of the returned cables. Customers with questions should call 978-256-4200 or 800-886-2966. For questions regarding this recall call 516-267-6502.

    Distribution

    Worldwide Distribution - US including CA, FL, MA, MD, MI, MN, MS, OH, PA, VA, TX & WV; **International**Australia, Bangladesh, Greece, Italy, Japan, Lebanon, Russian Federation, Singapore, Spain & Vietman.

    Quantity

    370 boxes (US - 159 boxes, OUS - 211 boxes)