Device product
Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340-89455-00 02340-89456-14 02340-89456-14 02340-89455-00 02340-95767-00 02340-89456-14 02340-89457-00 02340-89456-14 02340-89456-14 02340-89455-00 02340-89455-00 02340-95767-00 02340-95767-00
Z-0993-2019
Product summary
- Event
- Event 81964
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1761044
- Official record key
device-enforcement:Z-0993-2019
Official wording
Reason: Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.
Code information: 1000314778 1000289702 1000322841 1000329839 1000317735 1000323210 1000318792 1000170515 1000240186 1000378288 1000183941 1000350794 1000270527 1000277098
Distribution pattern: Nationwide domestic distribution. Foreign distribution to Barbados, Jamaica, Aruba, Guyana, Haiti, and St Maarten.
Derived failure modes
-
Unknown
Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.