Medical device recalls Moderate risk

Reckitt Benckiser LLC recalls Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340-89455-00 02340-89456-14 02340-89456-14 023…

Recall date
December 19, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0993-2019
FDA classification
Class II
Brand / firm
Reckitt Benckiser LLC
Sold / distributed
Nationwide domestic distribution. Foreign distribution to Barbados, Jamaica, Aruba, Guyana, Haiti, and St Maarten.

Why it was recalled

Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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