BEUDAMED
    FDA Recall Terminated

    The Baylis LumbarCool Pain Management Kit consisting of: 1 LumbarCool Pain Management Probe, 3 LumbarCool Pain Management introducers, and 1 Pain Management Tube Kit. Model/Catalogue Number: LUK-17-150-4 The LumbarCool Pain Management System, a cooled radiofrequency pain management system, in combination with the Baylis Pain Management Generator-TD (PMG-TD), is indicated for use to create RF lesions in nervous tissue.

    Recall: Z-1755-2010 · Initiated May 12, 2010

    Recall

    Recall Number
    Z-1755-2010
    Event Number
    55693
    Firm
    Baylis Medical Corp
    FEI Number
    3005241199
    Product Code
    GXI
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    May 12, 2010
    Posted
    June 3, 2010
    Terminated
    October 4, 2010
    Address
    5959 Trans-Canada Hwy, Montreal Canada

    Description

    The Baylis LumbarCool Pain Management Kit consisting of: 1 LumbarCool Pain Management Probe, 3 LumbarCool Pain Management introducers, and 1 Pain Management Tube Kit. Model/Catalogue Number: LUK-17-150-4 The LumbarCool Pain Management System, a cooled radiofrequency pain management system, in combination with the Baylis Pain Management Generator-TD (PMG-TD), is indicated for use to create RF lesions in nervous tissue.

    Reason

    Name of the device reflected on the product packing sleeve is incorrect.

    Action

    The firm, Baylis Medical, notified US Distributor by email and sent a "URGENT Field Corrective Action Notice" dated May 12, 2010, to customer. The notifications described the product, problem and action to be taken by customer. The customers were given the follow options: Option 1: In order to prevent confusion in identification of the product before use, please immediately remove and dispose the package sleeve that covers the tray packaging of the LumbarCool Pain Management Kit. Option 2: Alternatively, you may exchange your kit from Lot LKFA160310 with a correctly labeled replacement LumbarCool Pain Management Kit by contacting Kimberly-Clark Health Care sales representative. The customers were ask to fill out the Field Corrective Action Acknowledgment and return it. Any question please call Baylis Sales Representative at 905-602-4875 and/or contact your local sales representative for any further information you may require.

    Distribution

    Nationwide distribution: TX

    Quantity

    58