Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340-89455-00 02340-894...
FDA Recall #Z-0993-2019 — Class II — December 19, 2018
Product 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 for Recall
Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.
Recalling Firm
Reckitt Benckiser LLC — Parsippany, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1761044
Distribution
Nationwide domestic distribution. Foreign distribution to Barbados, Jamaica, Aruba, Guyana, Haiti, and St Maarten.
Code Information
1000314778 1000289702 1000322841 1000329839 1000317735 1000323210 1000318792 1000170515 1000240186 1000378288 1000183941 1000350794 1000270527 1000277098
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated