Z-0994-2019 Class II Terminated
FDA device recall Z-0994-2019 was initiated by Reckitt Benckiser LLC on December 19, 2018 and is designated Class II. Reason for recall: Five batches of the product have failed the specification of 1.0kPa for Burst Pressure. The recall status is terminated (terminated March 26, 2021). Affected quantity: 34920.
Recall Details
- Product Type
- Devices
- Report Date
- March 20, 2019
- Initiation Date
- December 19, 2018
- Termination Date
- March 26, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34920
Product Description
Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00
Reason for Recall
Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.
Distribution Pattern
Nationwide domestic distribution. Foreign distribution to Barbados, Jamaica, Aruba, Guyana, Haiti, and St Maarten.
Code Information
WO00905865 WO00905864 WO00901945 WO00900899 WO00900900 WO00900901