Kenvue Brands LLC
Summit, NJ, US
Kenvue Brands LLC appears in FDA device records in Summit, NJ. FDA records list 2 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 10 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Kenvue Brands LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Johnson & Johnson Consumer, Inc.510(k), enforcement report, recall
- Mc-NEIL-PPC, Inc.enforcement report, recall
510(k) clearance history
FDA records hold 2 510(k) clearances for Kenvue Brands LLC in 2018.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 2 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2214133 | 2214133 | Kenvue Brands LLC | 1 Kenvue Way, Summit, NJ 07901 US | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FQMBandage, Elastic
- NUPCream, Nasal, Topical, Mechanical Allergen Particle Barrier
- NADDressing, Wound, Occlusive
- FRLFiber, Medical, Absorbent
- LRRFirst Aid Kit With Drug
- OHOFirst Aid Kit Without Drug
- NABGauze / Sponge,Nonresorbable For External Use
- OHSLight Based Over The Counter Wrinkle Reduction
- ERAOtoscope
- OLPOver-The-Counter Powered Light Based Laser For Acne
- IMDPack, Hot Or Cold, Disposable
- KGXTape And Bandage, Adhesive
- LBHVarnish, Cavity
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1206-2018 | Johnson & Johnson BAND-AID Brand First Aid Products HURT-FREE Wrap (size: 2in) | Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in the U.S. of select COACH Self-Adhering Sports Wraps, BAND-AID Brand First Aid Products SECURE-FLEX Wraps and BAND-AID Brand First Aid Products HURT-FREE Wraps products. The current labeling claim states not made with natural rubber latex which needs to be updated based upon recent awareness that natural latex was used as a base ingredient in the early-stage manufacturing process, which reduces the allergic protein found in natural latex. | Class II | Terminated | |
| Z-1205-2018 | Johnson & Johnson BAND-AID Brand First Aid Products HURT-FREE Wrap (size: 1in) | Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in the U.S. of select COACH Self-Adhering Sports Wraps, BAND-AID Brand First Aid Products SECURE-FLEX Wraps and BAND-AID Brand First Aid Products HURT-FREE Wraps products. The current labeling claim states not made with natural rubber latex which needs to be updated based upon recent awareness that natural latex was used as a base ingredient in the early-stage manufacturing process, which reduces the allergic protein found in natural latex. | Class II | Terminated | |
| Z-1204-2018 | Johnson & Johnson BAND-AID Brand First Aid Products SECURE-FLEX Wrap (size: 3in) | Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in the U.S. of select COACH Self-Adhering Sports Wraps, BAND-AID Brand First Aid Products SECURE-FLEX Wraps and BAND-AID Brand First Aid Products HURT-FREE Wraps products. The current labeling claim states not made with natural rubber latex which needs to be updated based upon recent awareness that natural latex was used as a base ingredient in the early-stage manufacturing process, which reduces the allergic protein found in natural latex. | Class II | Terminated | |
| Z-1203-2018 | Johnson & Johnson BAND-AID Brand First Aid Products SECURE-FLEX Wrap (size: 2in) | Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in the U.S. of select COACH Self-Adhering Sports Wraps, BAND-AID Brand First Aid Products SECURE-FLEX Wraps and BAND-AID Brand First Aid Products HURT-FREE Wraps products. The current labeling claim states not made with natural rubber latex which needs to be updated based upon recent awareness that natural latex was used as a base ingredient in the early-stage manufacturing process, which reduces the allergic protein found in natural latex. | Class II | Terminated | |
| Z-1202-2018 | COACH Self-Adhering Sports Wrap (size: 3in) | Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in the U.S. of select COACH Self-Adhering Sports Wraps, BAND-AID Brand First Aid Products SECURE-FLEX Wraps and BAND-AID Brand First Aid Products HURT-FREE Wraps products. The current labeling claim states not made with natural rubber latex which needs to be updated based upon recent awareness that natural latex was used as a base ingredient in the early-stage manufacturing process, which reduces the allergic protein found in natural latex. | Class II | Terminated | |
| Z-1201-2018 | COACH Self-Adhering Sports Wrap (size: 2in) | Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in the U.S. of select COACH Self-Adhering Sports Wraps, BAND-AID Brand First Aid Products SECURE-FLEX Wraps and BAND-AID Brand First Aid Products HURT-FREE Wraps products. The current labeling claim states not made with natural rubber latex which needs to be updated based upon recent awareness that natural latex was used as a base ingredient in the early-stage manufacturing process, which reduces the allergic protein found in natural latex. | Class II | Terminated | |
| Z-0875-2013 | KY TINGLING JELLY Personal Lubricant. The product is packaged into 5 oz tubes with the UPC printed on it. Distributed By: McNeil-PPC Inc. | This product is not cleared for marketing in the US. | Class II | Terminated | |
| Z-0874-2013 | KY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged in 2.5 oz bottles, which are then packed into a printed carton. Distributed by McNeil-PPC Inc. | This product is not cleared for marketing in the US. | Class II | Terminated | |
| Z-0873-2013 | KY SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz tubes, which are then packed into a printed carton. Distributed by McNeil-PPC Inc. | This product is not cleared for marketing in the US. | Class II | Terminated | |
| Z-2467-2012 | KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant | Johnson & Johnson Healthcare Products (JJHP) is voluntarily recalling this product to address FDA concerns that the product should have been cleared under a separate medical device application. This voluntary recall is not being conducted on the basis of any consumer safety or product performance issues related to K-Y LIQUIBEADS. JJHP received a Warning Letter on May 23, 2012 indicating that thi | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain