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U.S. Department of Health and Human Services

Class 2 Device Recall HYPA C7

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  Class 2 Device Recall HYPA C7 see related information
Date Initiated by Firm November 13, 2002
Date Posted December 31, 2002
Recall Status1 Terminated 3 on January 04, 2005
Recall Number Z-0400-03
Recall Event ID 25016
Product Classification Lenses, Soft Contact, Daily Wear - Product Code LPL
Product Cosmetic color soft contact lenses. Multiple colors which include Blue, Green, Aqua, Brown, Grey.

BesCon (brand)
Code Information Lot numbers BB63 and BB73 on containers that hold lenses. Lot number 123410 is on inner box that holds 3 pairs of lenses.
Recalling Firm/
Manufacturer		 My Cosmetics Inc
9950 Bell Ranch Dr Ste 106
Santa Fe Springs CA 906706159
For Additional Information Contact Harry Han
562-903-7740
Manufacturer Reason
for Recall		 Products are being distributed from importer directly to retail outlets labeled 'for cosmetic use only'
FDA Determined
Cause 2		 Other
Action Firm began to telephone contact recall customers on 11/20/2002. Letters will also be sent requesting return of any remaining stock.
Distribution Nationwide. States of AL, AR, CA, DE, FL, GA, KY, LA, MD, MS, MO, NV, NY, NC, NE, OK, TN, TX, WA.
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.
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