BEUDAMED
    FDA Recall Terminated

    U by Kotex Sleek, Regular Tampons, 18 Count

    Recall: Z-0748-2019 · Initiated December 11, 2018

    Recall

    Recall Number
    Z-0748-2019
    Event Number
    81759
    Firm
    Kimberly-Clark Corporation
    FEI Number
    3003701733
    Product Code
    HEB
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 11, 2018
    Terminated
    June 2, 2021
    Address
    2100 Winchester Rd Po Box 349, Neenah, WI, 54956-9317

    Description

    U by Kotex Sleek, Regular Tampons, 18 Count

    Reason

    Potential for tampon to come apart upon removal.

    Action

    Kimberly-Clark issued a press release on 12/20/2018 and also notified customers via a "MEDICAL DEVICE RECALL" letter. The press release instructed consumers to stop using the product immediately and promptly contact Kimberly-Clark's Consumer Service team at 1-888-255-3499 between 7:30 a.m. 7:00 p.m. Central Time, Monday through Friday, for information regarding this recall. It also indicated that retailers have been alerted to remove the recalled lot numbers from shelves and post a notification in their stores. The customer letter instructed customers to review their store and distribution center inventory to remove affected product from store shelves and inventory, and to post the recall letter in their store. Any affected product should be placed on hold and arrangements should be made with Stericycle at 877-567-9324 for pickup and removal of affected product. If affected product is returned from retail stores, those customers should also make arrangements to send that product to Stericycle. Customers were also provided with and asked to complete and return the provided "Medical Device Recall Form." Questions should be directed to Kimberly-Clark's Consumer Care Team (1-888-255-3499), between 7:30 a.m. 7:00 p.m. Central Time, Monday through Friday. Consumers who experience vaginal injury (pain, bleeding, or discomfort), vaginal irritation (itching or swelling), urogenital infections (bladder and/or vaginal bacterial and/or yeast infections), or other symptoms such as hot flashes, abdominal pain, nausea, or vomiting following use of the impacted product should seek immediate medical attention.

    Distribution

    Nationwide distribution AR, AZ, CA, CT, FL, HI, IA, ID, IL, KS, LA, MA, MD, MI, MN, MO, MS, NC, NH, NY, OH, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI. International distribution to Canada.

    Quantity

    68,852,076 units total