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).
Z-0091-2019
Product summary
- Event
- Event 80939
- Status
- Terminated
- Classification
- Class II
- Quantity
- 34 cartons/12 condoms each (408 condoms total)
- Official record key
device-enforcement:Z-0091-2019
Official wording
Reason: 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
Code information: Lot Number - 1000490884
Distribution pattern: US in the states of NY
Derived failure modes
-
Unknown
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