FDA Enforcement
Class II
Terminated
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).
Recall: Z-0091-2019
·
Reported October 17, 2018
Enforcement
- Recall Number
- Z-0091-2019
- Event ID
- 80939
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Reckitt Benckiser LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 17, 2018
- Initiation Date
- August 6, 2018
- Classification Date
- October 9, 2018
- Termination Date
- November 12, 2019
- Address
- 399 Interpace Pkwy, Parsippany, NJ, 07054-1133, United States
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
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
Code Info
Lot Number - 1000490884
Distribution
US in the states of NY
Quantity
34 cartons/12 condoms each (408 condoms total)