Atlas FDA

Lubricated Latex Condom. Labeled in part: "COMING TOGETHER IN DC", Distributed by Global Protection Corp., #12 Channel S

FDA device recall Z-0054-2008 · posted 2007-12-11 · Terminated

Recall details

Recalling firm
Global Protection Corp.
Reason for recall
Condoms fail the water leak test and package integrity
Action taken
Global Protection Corp. recalled product by email on 9/11/07
Root cause
Process control
Status
Terminated
Product code
HIS
Quantity affected
127,00 condoms
Distribution
The District of Columbia Health Department
Date initiated
2007-09-11
Date posted
2007-12-11
Date terminated
2008-03-18
Location
Boston, MA

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Related 510(k) clearances

RecordFirmDate
OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS (K994118)Guilin Latex Factory2000-08-14