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FDA Medical Device Recalls (openFDA)

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

Recall number
Z-0054-2008
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
Status
Terminated
Initiated
2007-09-11
Posted
2007-12-11
Terminated
2008-03-18
Reason
Condoms fail the water leak test and package integrity
Root cause
Process control
Action
Global Protection Corp. recalled product by email on 9/11/07
Quantity
127,00 condoms
Distribution
The District of Columbia Health Department
Lot, serial or model codes
Lot Number: 9907109 Expiration:04/2012
510(k) numbers
["K994118"]
PMA numbers
not on file
Product code
HIS
Firm FEI
1222115
Firm city
Boston
Firm state
MA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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