BEUDAMED
    FDA Enforcement Class II Terminated

    Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue.

    Recall: Z-2391-2016 · Reported August 17, 2016

    Enforcement

    Recall Number
    Z-2391-2016
    Event ID
    74553
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Halyard Health, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 17, 2016
    Initiation Date
    June 16, 2016
    Classification Date
    August 11, 2016
    Termination Date
    September 8, 2016
    Address
    5405 Windward Pkwy, Alpharetta, GA, 30004-3894, United States

    Description

    Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue.

    Reason

    Mismatch between the length of the RF electrode (probe) and the cannula (introducer),

    Code Info

    Lot Number M5264D205

    Distribution

    Distributed in the states of CT, IL, MA, MI, NV, NH, NC, and TX, and the country of Canada.

    Quantity

    51 kits