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Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-98729-00 02340-98729-0...

FDA Recall #Z-0994-2019 — Class II — December 19, 2018

Recall #Z-0994-2019 Date: December 19, 2018 Classification: Class II Status: Terminated

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.

Recalling Firm

Reckitt Benckiser LLC — Parsippany, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

34920

Distribution

Nationwide domestic distribution. Foreign distribution to Barbados, Jamaica, Aruba, Guyana, Haiti, and St Maarten.

Code Information

WO00905865 WO00905864 WO00901945 WO00900899 WO00900900 WO00900901

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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