BEUDAMED
    FDA Recall 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 · Initiated October 29, 2013

    Recall

    Recall Number
    Z-0850-2014
    Event Number
    66832
    Firm
    Kimberly-Clark Corporation
    FEI Number
    1000015879
    Product Code
    GXI
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    October 29, 2013
    Posted
    January 28, 2014
    Terminated
    September 3, 2014
    Address
    1400 Holcomb Bridge Rd, Roswell, GA, 30076-2190

    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.

    Action

    The firm, Kimberly-Clark Corporation, sent an "URGENT: Voluntary Medical Device Recall Notification" letter dated October 29, 2013 to all direct customers and distributors via federal express priority overnight. The letter described the product, problem and actions to be taken. The customers were instructed to evaluate your Facility's inventory of Kimberly-Clark RadiOpaque Radiofrequency Cannula to determine if any of the two impacted product lots remain within your facility. If product is present, discontinue use of the impacted product and place in a quarantined location; complete and return the attached Product Recall Response Form-Customers via fax to: 1-920-225-4182 within five (5) business days of receipt of this letter (complete and return form even if either of the impacted product lots is NOT present in your facility). Once response form is received, a Kimberly-Clark representative will contact you regarding return and replacement of the product. If you require further assistance, please call Kimberly-Clark Customer Service at 800-KC-HELPS (800-524-3577).

    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)