Recall Z-0993-2019— Reckitt Benckiser LLC

Name: FDA recall Z-0993-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-19

Class II · Terminated

Class II FDA medical device recall by Reckitt Benckiser LLC, initiated 2018-12-19, terminated 2021-03-26. It names one FDA 510(k) clearance: K072169. Product: 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: Five batches of the product have failed the specification of 1.0kPa for Burst Pressure..

Recalling firm: Reckitt Benckiser LLC
Classification: Class II
Status: Terminated
Initiated: 2018-12-19
Terminated: 2021-03-26
Firm location: Parsippany, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K072169 — DUREX SYNTHETIC POLYISOPRENE MALE CONDOMSsl Americas, Inc.·cleared 2008-06-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.