BEUDAMED
    FDA Recall 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 · Initiated June 16, 2016

    Recall

    Recall Number
    Z-2391-2016
    Event Number
    74553
    Firm
    Halyard Health, Inc
    FEI Number
    3011270181
    Product Code
    GXI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 16, 2016
    Terminated
    September 8, 2016
    Address
    5405 Windward Pkwy, Alpharetta, GA, 30004-3894

    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),

    Action

    All distributors and healthcare facilities that were directly shipped recalled devices were notified of the recall beginning 6/16/2016 by email and by FedEx. They were instructed to examine their stock and to quarantine and discontinue use of the product. The letter contained a response form which was to faxed back to Halyard.

    Distribution

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

    Quantity

    51 kits