Medical device recalls Moderate risk

Reckitt Benckiser LLC recalls Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00 Product Usag…

Recall date
July 23, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-3241-2018
FDA classification
Class II
Brand / firm
Reckitt Benckiser LLC
Sold / distributed
US Nationwide.

Why it was recalled

The products failed the filed 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 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).

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