Recall Z-0994-2019 ยท MOL Condom, Synthetic
Reckitt Benckiser LLC
Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00
| Date | Mar 9, 2019 (initiated Dec 19, 2018) |
| Status | Terminated |
| Reason | Five batches of the product have failed the specification of 1.0kPa for Burst Pressure. |
| Root cause | Under Investigation by firm |
| Action | On December 19, 2018, the firm issued Urgent Medical Device Recall letters to wholesale customers. The letter advised customers of the product issue, and reminded customers that the product labeling states, "Should a condom break or leak during use, seek medical assistance as soon as possible, at least within 72 hrs." Customers are asked to do the following: 1. Examine inventory in your distribution center immediately to determine if you have the specified batch in your warehouse inventory. 2. Segregate and return the specified batch. 3. A pre-paid return label is provided by the firm for yo |
| Quantity | 34920 |
| Distribution | Nationwide domestic distribution. Foreign distribution to Barbados, Jamaica, Aruba, Guyana, Haiti, and St Maarten. |
| 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 |