FDA recall Z-3241-2018

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 for recall

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

Distribution

US Nationwide.

Key facts

Status

Terminated

Initiation date

2018-07-23

Report date

2018-10-03

Termination date

2020-03-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3241-2018