FDA-Device2019-03-20Class II

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

Reckitt Benckiser LLC
Hazard

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

Sold states
Nationwide domestic distribution. Foreign distribution to Barbados, Jamaica, Aruba, Guyana, Haiti, and St Maarten.
Affected count
34920
Manufactured in
399 Interpace Pkwy, N/A, Parsippany, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0994-2019

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