Recall Z-0091-2019 ยท MOL Condom, Synthetic
Reckitt Benckiser LLC
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).
| Date | Aug 6, 2018 |
| Status | Terminated |
| 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 |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 34 cartons/12 condoms each (408 condoms total) |
| Distribution | US in the states of NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072169 | DUREX SYNTHETIC POLYISOPRENE MALE CONDOM Ssl Americas, Inc., Jun 19, 2008 |