Recall Z-0091-2019— Reckitt Benckiser LLC
Class II · Terminated
Class II FDA medical device recall by Reckitt Benckiser LLC, initiated 2018-08-06, terminated 2019-11-12. It names one FDA 510(k) clearance: K072169. Product: 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.
- Recalling firm
- Reckitt Benckiser LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-08-06
- Terminated
- 2019-11-12
- Firm location
- Parsippany, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.