FDA Enforcement
Class II
Terminated
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
Recall: Z-0993-2019
·
Reported March 20, 2019
Enforcement
- Recall Number
- Z-0993-2019
- Event ID
- 81964
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Reckitt Benckiser LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 20, 2019
- Initiation Date
- December 19, 2018
- Classification Date
- March 8, 2019
- Termination Date
- March 26, 2021
- Address
- 399 Interpace Pkwy, N/A, Parsippany, NJ, 07054-1133, United States
Description
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
Reason
Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.
Code Info
1000314778 1000289702 1000322841 1000329839 1000317735 1000323210 1000318792 1000170515 1000240186 1000378288 1000183941 1000350794 1000270527 1000277098
Distribution
Nationwide domestic distribution. Foreign distribution to Barbados, Jamaica, Aruba, Guyana, Haiti, and St Maarten.
Quantity
1761044