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
|
|
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
|