Recall Z-0749-2019 ยท HEB Tampon, Menstrual, Unscented
Kimberly-Clark Corporation
U by Kotex Sleek, Regular Tampons, 34 Count
| Date | Dec 11, 2018 |
| Status | Terminated |
| Reason | Potential for tampon to come apart upon removal. |
| Root cause | Under Investigation by firm |
| 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 distributi |
| Quantity | 68,852,076 units total |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112635 | U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS Kimberly-Clark Corp., Oct 7, 2011 |