Z-0091-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 17, 2018
- Initiation Date
- August 6, 2018
- Termination Date
- November 12, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34 cartons/12 condoms each (408 condoms total)
Product Description
Polyisoprene condomns 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
Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal burst pressure specifications at the end of 5 yrs shelf-life
Distribution Pattern
US in the states of NY
Code Information
Lot Number - 1000490884