Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0054-2008

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

Global Protection Corp. / initiated 2007-09-11 / Terminated / root cause: manufacturing process

Global Protection Corp. began a recall of Lubricated Latex Condom. Labeled in part: "COMING TOGETHER IN DC", Distributed by Global Protection Corp., #12 Channel Street, Boston, MA on . The reason FDA records is "Condoms fail the water leak test and package integrity". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0054-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Global Protection Corp.
Product
Lubricated Latex Condom. Labeled in part: "COMING TOGETHER IN DC", Distributed by Global Protection Corp., #12 Channel Street, Boston, MA
Product code
HIS Condom
Reason for recall
Condoms fail the water leak test and package integrity
Root cause tag
manufacturing process
FDA root cause
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
Product codes and lots
Lot Number: 9907109 Expiration:04/2012