FDA recall Z-0091-2019

Reckitt Benckiser LLC · Class II · device

Product

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).

Reason for recall

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

Distribution

US in the states of NY

Key facts

Status
Terminated
Initiation date
2018-08-06
Report date
2018-10-17
Termination date
2019-11-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0091-2019