BEUDAMED
    FDA Enforcement Class II Terminated

    Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Active Tip 10 mm, Distributed in the US by Kimberly-Clark,Product code PMF22-100-10 The product is used to create lesions in nervous tissue when used with the Kimberly-Clark radiofrequency generator and probes.

    Recall: Z-0850-2014 · Reported February 5, 2014

    Enforcement

    Recall Number
    Z-0850-2014
    Event ID
    66832
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Kimberly-Clark Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 5, 2014
    Initiation Date
    October 29, 2013
    Classification Date
    January 28, 2014
    Termination Date
    September 3, 2014
    Address
    1400 Holcomb Bridge Rd, Roswell, GA, 30076-2190, United States

    Description

    Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Active Tip 10 mm, Distributed in the US by Kimberly-Clark,Product code PMF22-100-10 The product is used to create lesions in nervous tissue when used with the Kimberly-Clark radiofrequency generator and probes.

    Reason

    Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated on the label.

    Code Info

    Lot M3085K301 and M2327K301

    Distribution

    US Distribution in states of: AZ, CA, DE, FL, LA, MD, MA, NJ, NY, OH, PA and TX.

    Quantity

    55 cases (10 units per case = 550 units)