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U.S. Department of Health and Human Services

Class 2 Device Recall Global Protection Corp

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  Class 2 Device Recall Global Protection Corp see related information
Date Initiated by Firm September 11, 2007
Date Posted December 11, 2007
Recall Status1 Terminated 3 on March 18, 2008
Recall Number Z-0054-2008
Recall Event ID 45525
510(K)Number K994118  
Product Classification Condom - Product Code HIS
Product Lubricated Latex Condom. Labeled in part: "COMING TOGETHER IN DC", Distributed by Global Protection Corp., #12 Channel Street, Boston, MA
Code Information Lot Number: 9907109 Expiration:04/2012
Recalling Firm/
Global Protection Corp.
12 Channel St Fl 6th
Boston MA 02210-2323
Manufacturer Reason
for Recall
Condoms fail the water leak test and package integrity
FDA Determined
Cause 2
Process control
Action Global Protection Corp. recalled product by email on 9/11/07
Quantity in Commerce 127,00 condoms
Distribution The District of Columbia Health Department
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 = HIS and Original Applicant = GUILIN LATEX FACTORY