BEUDAMED
    FDA Enforcement Class II 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 · Reported December 21, 2016

    Enforcement

    Recall Number
    Z-0748-2017
    Event ID
    75351
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ellman International, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 21, 2016
    Initiation Date
    September 7, 2016
    Classification Date
    December 13, 2016
    Termination Date
    June 18, 2018
    Address
    400 Karin Ln, Hicksville, NY, 11801-5352, United States

    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.

    Code Info

    Lot Numbers 45572 (Box), (Individual packages) 48543, 50382, 48543, 50704, 50858 Exp Date - 2018-02

    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)