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
- Recall Number
- Z-0091-2019
- Event Number
- 80939
- Firm
- Reckitt Benckiser LLC
- FEI Number
- 3011015568
- Product Code
- MOL
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- August 6, 2018
- Terminated
- November 12, 2019
- Address
- 399 Interpace Pkwy, Parsippany, NJ, 07054-1133
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).
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
On August 6,. 2018, Reckitt Benckiser issued Urgent Medical Device Recall notices to customers. Customers were advised to take the following action: Wholesale Customers: 1. Examine inventory and quarantine affected product 2. Contact customers and notify them of the recall and provide them with the recall instructions (copy of the letter). 3. Customers are encouraged to contact Stericycle Expert Solutions at 877-448-5308 for assistance if additional return labels are required or help with coordination of pickup and removal of product from your facility.
US in the states of NY
34 cartons/12 condoms each (408 condoms total)