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U.S. Department of Health and Human Services

Class 2 Device Recall Life Brand Regular Absorbency 40 Count Unscented Plastic Applicator Tampons

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  Class 2 Device Recall Life Brand Regular Absorbency 40 Count Unscented Plastic Applicator Tampons see related information
Date Initiated by Firm March 25, 2010
Date Posted September 22, 2010
Recall Status1 Terminated 3 on October 06, 2010
Recall Number Z-2466-2010
Recall Event ID 56303
510(K)Number K023479  
Product Classification Tampon, menstrual, unscented - Product Code HEB
Product Life Brand Regular Absorbency 40 Count Unscented Plastic Applicator Tampons
Code Information Lot 09DPC24P UPC #0-57800-23314-5
Recalling Firm/
Manufacturer		 First Quality Hygienic Inc
North Rd,Box 330
Mc Elhattan PA 17748
For Additional Information Contact Michael R. Weaver
570-769-4449
Manufacturer Reason
for Recall		 Life Brand Regular Absorbency 40 Count Unscented Plastic Applicator Tampons package contained Super Plus Unscented Plastic Applicator Tampons.
FDA Determined
Cause 2		 Labeling mix-ups
Action Consignees were notified via telephone and letter of the need to withdraw product from the market and requested to return all product to manufacturer.
Quantity in Commerce 195 Cases/2340 Cartons
Distribution Canada
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = HEB and Original Applicant = FIRST QUALITY HYGIENIC, INC.
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