Recall Z-0393-2012 ยท HEB Tampon, Menstrual, Unscented
Kimberly-Clark Corporation
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.
| Date | Jan 11, 2012 (initiated Nov 3, 2011) |
| Status | Terminated |
| 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. |
| Root cause | Material/Component Contamination |
| 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. |
| Quantity | 1400 Cases (216 tampons per case) |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K896994 | KOTEX SECURITY TAMPONS (SEVERAL TYPE) Kimberly-Clark Corp., Dec 22, 1989 |