Recall Z-0393-2012
Kimberly-Clark Corporation · initiated November 3, 2011
Product
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.
Codes / lots: Lot numbers (found in the red box located on bottom of package): 18-count: AC129321X, AC129421X, AC129521X, AC129621X, AC129721X, AC129821X, AC129921X 36 count: AC129325X, AC129425X, AC129525X, AC129625X, AC129725X, AC129825X, AC129925X
Reason for recall
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.
FDA-determined cause: Material/Component Contamination
Action taken
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.
Details
- Recall number
- Z-0393-2012
- Initiated
- November 3, 2011
- Posted by FDA
- January 11, 2012
- Terminated
- December 13, 2012
- Product code
- HEB – Tampon, Menstrual, Unscented
- Quantity
- 1400 Cases (216 tampons per case)
- Distribution
- Nationwide Distribution
- Recalling firm
- Kimberly-Clark Corporation, Roswell, GA