ClearanceBrief
Recall Z-0054-2008 ยท HIS Condom

Global Protection Corp.

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

DateDec 11, 2007 (initiated Sep 11, 2007)
StatusTerminated
ReasonCondoms fail the water leak test and package integrity
Root causeProcess control
ActionGlobal Protection Corp. recalled product by email on 9/11/07
Quantity127,00 condoms
DistributionThe District of Columbia Health Department
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K994118OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS
Guilin Latex Factory, Aug 14, 2000