Reckitt Benckiser, LLC
Medical device manufacturer in Parsippany, NJ.
9510(k) clearances
0PMA approvals
5recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K173504 | K-Y SiliconeNUC · Traditional | 01/12/2018SE |
| K151884 | K-Y Marilyn Pleasure GelNUC · Traditional | 01/11/2016SE |
| K143532 | Durex SiliconeNUC · Traditional | 07/31/2015SE |
| K143511 | K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal LubricantNUC · Traditional | 05/20/2015SE |
| K131643 | Durex Realfeel Pleasure Gel Personal LubricantNUC · Traditional | 12/17/2014SE |
| K140193 | Durex Embrace Personal LubricantNUC · Traditional | 11/04/2014SE |
| K990703 | Sporox II Sterilizing & Disinfecting SolutionMED · Special | 03/30/1999SE |
| K970230 | SporoxMED · Traditional | 10/29/1997SE |
| K963353 | Lysol I.C. Brand Phenolic Disinfectant Cleaner (Epa Reg. No. 675-46)LRJ · Traditional | 10/18/1996SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0994-2019 Class II | Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-98729-00…Five batches of the product have failed the specification of 1.0kPa for Burst Pressure. | 12/19/2018Terminated |
| Z-0993-2019 Class II | Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340-89455-00…Five batches of the product have failed the specification of 1.0kPa for Burst Pressure. | 12/19/2018Terminated |
| Z-0091-2019 Class II | Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male condom is…Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal burst… | 08/06/2018Terminated |
| Z-3241-2018 Class II | Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14…The products failed the filed specification of 1.0kPa for Burst Pressure. | 07/23/2018Terminated |
| Z-1249-2017 Class II | Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubricated…Reckitt Benckiser LLC is recalling Durex Condoms Pleasure Packs due to missing information on the package… | 11/22/2016Terminated |