Atlas FDA

Assorted colored and flavored condoms: LifeStyles Luscious Flavors, Prime Assorted Colors, Contempo Luscious Flavors, Co

FDA device recall Z-0401-03 · posted 2002-12-31 · Terminated

Recall details

Recalling firm
Ansell Healthcare Inc
Reason for recall
The condoms are being recalled because information recently available indicates some of these condoms do not meet airburst test standards
Action taken
Recall letters dated 11/25/02 were issued to direct accounts via U.S. Mail, asking wholesalers to stop distribution of the lot, return stocks on hand, and conduct a recall to the retail level.
Root cause
Other
Status
Terminated
Product code
HIS
Quantity affected
approximately 40 million condoms
Distribution
Nationwide and Europe
Date initiated
2002-11-25
Date posted
2002-12-31
Date terminated
2003-10-15
Location
Dothan, AL

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