Z-3241-2018 Class II Terminated
FDA device recall Z-3241-2018 was initiated by Reckitt Benckiser LLC on July 23, 2018 and is designated Class II. Reason for recall: The products failed the filed specification of 1.0kPa for Burst Pressure. The recall status is terminated (terminated March 5, 2020). Affected quantity: 487980 condoms.
Recall Details
- Product Type
- Devices
- Report Date
- October 3, 2018
- Initiation Date
- July 23, 2018
- Termination Date
- March 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 487980 condoms
Product Description
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).
Reason for Recall
The products failed the filed specification of 1.0kPa for Burst Pressure.
Distribution Pattern
US Nationwide.
Code Information
Batch Numbers: 1000427177, 1000408620, 1000430764