Z-0091-2019 Class II Terminated
FDA device recall Z-0091-2019 was initiated by Reckitt Benckiser LLC on August 6, 2018 and is designated Class II. 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 The recall status is terminated (terminated November 12, 2019). Affected quantity: 34 cartons/12 condoms each (408 condoms total).
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