FDA-Device2018-10-17Class II
Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
Reckitt Benckiser LLC
Hazard
Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal burst pressure specifications at the end of 5 yrs shelf-life
Sold states
US in the states of NY
Affected count
34 cartons/12 condoms each (408 condoms total)
Manufactured in
399 Interpace Pkwy, Parsippany, NJ, United States
Products
Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0091-2019Don't want to check this manually?
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