Device product
Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00 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-3241-2018
Product summary
- Event
- Event 80841
- Status
- Terminated
- Classification
- Class II
- Quantity
- 487980 condoms
- Official record key
device-enforcement:Z-3241-2018
Official wording
Reason: The products failed the filed specification of 1.0kPa for Burst Pressure.
Code information: Batch Numbers: 1000427177, 1000408620, 1000430764
Distribution pattern: US Nationwide.
Derived failure modes
-
Unknown
The products failed the filed specification of 1.0kPa for Burst Pressure.