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Recall Observatory FDA recall evidence

Device product

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

Z-0994-2019

December 19, 2018

Class II

Product summary

Firm
Reckitt Benckiser LLC
Event
Event 81964
Status
Terminated
Classification
Class II
Quantity
34920
Official record key
device-enforcement:Z-0994-2019

Official wording

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

Code information: WO00905865 WO00905864 WO00901945 WO00900899 WO00900900 WO00900901

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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