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Z-0993-2019 Class II Terminated

Recalled by Reckitt Benckiser LLC — Parsippany, NJ

FDA device recall Z-0993-2019 was initiated by Reckitt Benckiser LLC on December 19, 2018 and is designated Class II. Reason for recall: Five batches of the product have failed the specification of 1.0kPa for Burst Pressure. The recall status is terminated (terminated March 26, 2021). Affected quantity: 1761044.

Recall Details

Product Type: Devices
Report Date: March 20, 2019
Initiation Date: December 19, 2018
Termination Date: March 26, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1761044

Product Description

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

Reason for Recall

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

Distribution Pattern

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

Code Information

1000314778 1000289702 1000322841 1000329839 1000317735 1000323210 1000318792 1000170515 1000240186 1000378288 1000183941 1000350794 1000270527 1000277098

Other recalls by Reckitt Benckiser LLC

Z-0994-2019 Class II — Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-98729- (December 19, 2018)
Z-0091-2019 Class II — Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male c (August 6, 2018)
Z-3241-2018 Class II — Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-8 (July 23, 2018)
Z-1249-2017 Class II — Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubr (November 22, 2016)
D-1517-2016 Class III — Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, (August 3, 2016)
D-1366-2015 Class I — Mucinex Fast Max Day Time Severe Cold and Fast-Max Night Time Cold & Flu Two - (April 15, 2015)
D-1368-2015 Class I — Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Maxim (April 15, 2015)
D-1364-2015 Class I — Mucinex Fast Max Night Time Cold & Flu, Maximum Strength, Acetaminophen Pain Rel (April 15, 2015)
D-1369-2015 Class II — Mucinex Fast Max DM Max, Maximum Strength, Dextromethorphan HBr Cough Suppressan (April 15, 2015)
D-1363-2015 Class I — Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pain R (April 15, 2015)