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
|
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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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