Kotex Natural Balance Security tampons, regular absorbency, unscented. packaged in 18 count or 36 count retail container
FDA device recall Z-0393-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Kimberly-Clark Corporation
- 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.
- 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.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- HEB
- Quantity affected
- 1400 Cases (216 tampons per case)
- Distribution
- Nationwide Distribution
- Date initiated
- 2011-11-03
- Date posted
- 2012-01-11
- Date terminated
- 2012-12-13
- Location
- Roswell, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KOTEX SECURITY TAMPONS (SEVERAL TYPE) (K896994) | Kimberly-Clark Corp. | 1989-12-22 |