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U.S. Department of Health and Human Services

Class 2 Device Recall Kotex tampons

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 Class 2 Device Recall Kotex tamponssee related information
Date Initiated by FirmNovember 03, 2011
Date PostedJanuary 11, 2012
Recall Status1 Terminated 3 on December 13, 2012
Recall NumberZ-0393-2012
Recall Event ID 60386
510(K)NumberK896994 
Product Classification Tampon, menstrual, unscented - Product Code HEB
ProductKotex 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.
Code Information 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 
Recalling Firm/
Manufacturer		 Kimberly-Clark Corporation
1400 Holcomb Bridge Rd
Roswell GA 30076
For Additional Information ContactConsumer Services Division
800-335-6839
Manufacturer 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 2		Material/Component Contamination
ActionKimberly-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 in Commerce1400 Cases (216 tampons per case)
DistributionNationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HEB
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