Recall Z-3241-2018— Reckitt Benckiser LLC

Name: FDA recall Z-3241-2018
Creator: U.S. Food and Drug Administration
Published: 2018-07-23

Class II · Terminated

Class II FDA medical device recall by Reckitt Benckiser LLC, initiated 2018-07-23, terminated 2020-03-05. It names one FDA 510(k) clearance: K072169. Product: Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00 Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).. Reason: The products failed the filed specification of 1.0kPa for Burst Pressure..

Recalling firm: Reckitt Benckiser LLC
Classification: Class II
Status: Terminated
Initiated: 2018-07-23
Terminated: 2020-03-05
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 Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00 Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).

Reason for recall

The products failed the filed specification of 1.0kPa for Burst Pressure.

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