Reckitt Benckiser LLC
Harrisburg, PA, US
Reckitt Benckiser LLC appears in FDA device records in Harrisburg, PA. FDA records list 9 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Reckitt Benckiser LLC between 1996 and 2018. The busiest year on record is 2014, with 2. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 1 |
| 1997 | 1 |
| 1999 | 1 |
| 2014 | 2 |
| 2015 | 2 |
| 2016 | 1 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K173504 | K-Y Silicone | NUC | Substantially Equivalent | |
| K151884 | K-Y Marilyn Pleasure Gel | NUC | Substantially Equivalent | |
| K143532 | Durex Silicone | NUC | Substantially Equivalent | |
| K143511 | K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal Lubricant | NUC | Substantially Equivalent | |
| K131643 | DUREX REALFEEL PLEASURE GEL PERSONAL LUBRICANT | NUC | Substantially Equivalent | |
| K140193 | DUREX EMBRACE PERSONAL LUBRICANT | NUC | Substantially Equivalent | |
| K990703 | SPOROX II STERILIZING & DISINFECTING SOLUTION | MED | Substantially Equivalent | |
| K970230 | SPOROX | MED | Substantially Equivalent | |
| K963353 | LYSOL I.C. BRAND PHENOLIC DISINFECTANT CLEANER (EPA REG. NO. 675-46) | LRJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2531449 | 3003979157 | Reckitt Benckiser LLC | 360 Independence Avenue, Harrisburg, PA 17102 US | 2026 | |
| 3011015568 | 3011015568 | Reckitt Benckiser LLC | 100 Metro Blvd, Nutley, NJ 07110 US | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HISCondom
- MOLCondom, Synthetic
- KYWContainer, Liquid Medication, Graduated
- LJLDetectors And Removers, Lice, (Including Combs)
- LKYDevice, External Penile Rigidity
- LRJDisinfectant, Medical Devices
- KYXDispenser, Liquid Medication
- NACDressing, Wound, Hydrophilic
- FRLFiber, Medical, Absorbent
- KMJLubricant, Patient
- NUCLubricant, Personal
- KCONasal Spray, Ent Delivery
- KNPOrthosis, Corrective Shoe
- IMEPack, Hot Or Cold, Reusable
- MEDSterilant, Medical Devices
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0994-2019 | 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 | Five batches of the product have failed the specification of 1.0kPa for Burst Pressure. | Class II | Terminated | |
| Z-0993-2019 | Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340-89455-00 02340-89456-14 02340-89456-14 02340-89455-00 02340-95767-00 02340-89456-14 02340-89457-00 02340-89456-14 02340-89456-14 02340-89455-00 02340-89455-00 02340-95767-00 02340-95767-00 | Five batches of the product have failed the specification of 1.0kPa for Burst Pressure. | Class II | Terminated | |
| Z-0091-2019 | 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 | Class II | Terminated | |
| Z-3241-2018 | 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). | The products failed the filed specification of 1.0kPa for Burst Pressure. | Class II | Terminated | |
| Z-1249-2017 | Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubricated latex condoms 24 Ra fine lubricated latex condoms 3 ct UPC 3-02340-30042-04-1 3 ct - Walmart UPC 02340-70042-04 12ct - UPC 3-02340-30274-08-6 24 ct - UPC 302340-302190-04 (contacting firm for label) | Reckitt Benckiser LLC is recalling Durex Condoms Pleasure Packs due to missing information on the package labeling associated with the active ingredient Benzocaine. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain