Recall Z-3241-2018 ยท MOL Condom, Synthetic
Reckitt Benckiser LLC
Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00 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 | Jul 23, 2018 |
| Status | Terminated |
| Reason | The products failed the filed specification of 1.0kPa for Burst Pressure. |
| Root cause | Under Investigation by firm |
| Action | On 7/23/18, an Urgent Medical Device Recall notification letter was distributed to customers. The letter instructed customers to do the following: 1. Examine your inventory in your distribution center immediately to determine if you have the specified batch in your warehouse inventory. 2. Segregate and quarantine the specified batch. 3. If you have product of the specified batch, contact our Stericycle representative immediately for a RETURN AUTHORIZATION number. a. Contact Information: Phone: 877-448-5308 Fax: 877-884-9410 4. Contact Stericycle Expert Solutions at 877-448-5308 for assistanc |
| Quantity | 487980 condoms |
| Distribution | US Nationwide. |
| 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 |