BEUDAMED
    FDA Recall Terminated

    Kotex Natural Balance Security tampons, regular absorbency, unscented. packaged in 18 count or 36 count retail containers. Consumer Services, Kimberly-Clark Corp. Dept. KNBTR-18, P.O. Box 2020, Neenah, WI 54957-2020 USA. To absorb menstrual or other vaginal discharge.

    Recall: Z-0393-2012 · Initiated November 3, 2011

    Recall

    Recall Number
    Z-0393-2012
    Event Number
    60386
    Firm
    Kimberly-Clark Corporation
    FEI Number
    1000015879
    Product Code
    HEB
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    November 3, 2011
    Posted
    January 11, 2012
    Terminated
    December 13, 2012
    Address
    1400 Holcomb Bridge Rd, Roswell, GA, 30076

    Description

    Kotex Natural Balance Security tampons, regular absorbency, unscented. packaged in 18 count or 36 count retail containers. Consumer Services, Kimberly-Clark Corp. Dept. KNBTR-18, P.O. Box 2020, Neenah, WI 54957-2020 USA. To absorb menstrual or other vaginal discharge.

    Reason

    A limited number of Kotex Natural Balance Security Unscented Tampons, regular absorbency, are being recalled after a raw material contaminated with a bacterium, Enterobacter sakazakii, was found when testing the plunger portion of the applicator.

    Action

    Kimberly-Clark sent an Urgent Product Recall letter, dated 11/09/2011, via FedEx to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify, quarantine, and discontinue use immediately. Customers were asked to complete the response form and fax to +1 (920) 380-6467. A Kimberly-Clark representative would contact them regarding return of the product, replenishement and/or account credit. For questions regarding this recall call +1 (920) 216-8152.

    Distribution

    Nationwide Distribution

    Quantity

    1400 Cases (216 tampons per case)