FDAFDA · Food and drugs·Recall number Z-0994-2019
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
Published March 20, 2019 · Recall initiated: December 19, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Reckitt Benckiser LLC
- Distributor
- Nationwide domestic distribution. Foreign distribution to Barbados, Jamaica, Aruba, Guyana, Haiti, and St Maarten.
- Lot
- WO00905865 WO00905864 WO00901945 WO00900899 WO00900900 WO00900901
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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