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/ Manufacturer |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = HIS
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