Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately in single, single syringe, 4 packs, 6 packs and in teeth whitening kits
Check against the official notice below — it lists the full affected range.
Discus Dental LLC is recalling Relief ACP Oral Care Gel, a product intended to relieve discomfort from dentin sensitivity. Products sold after April 1, 2014 were inadvertently filled with hydrogen peroxide teeth whitening gel (6% concentration) on one side of the dual barrel syringe instead of the intended phosphate gel component. This manufacturing error means that patients using the affected product may experience a neutral effect or increased sensitivity instead of the intended relief.
The recalled product was distributed worldwide, including 20,251 units in the United States and 14,653 units internationally across multiple countries. The affected products are identified by specific SKU numbers and lot numbers listed in the recall documentation. The recall notice does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Product sold after April 1, 2014 were inadvertently filled with hydrogen peroxide teeth whitening gel (6% concentration as dispensed) on one side of the dual barrel syringe instead of the intended component (phosphate gel). Consequently, use of this product by patients may result in a neutral effect or increased sensitivity.
Reason for recall: Product sold after April 1, 2014 were inadvertently filled with hydrogen peroxide teeth whitening gel (6% concentration as dispensed) on one side of the dual barrel syringe instead of the intended component (phosphate gel). Consequently, use of this product by patients may result in a neutral effect or increased sensitivity. Distribution: Worldwide distribution including Nationwide (U.S.) and the countries of New Zealand, Australia, Canada, Germany, Switzerland, Italy, Austria, Finland, South Africa, United Arab Emirates, Korea, Turkey, Egypt, Jordan, Thailand, Lebanon, Kuwait, Tunisia, India, and Dominican Republic. Quantity: 20,251 distributed in U.S. on nationwide level and 14,653 internationally Lot/code info: - List of Relief ACP Oral Care Gel products distributed in U.S. SKU Number Lot Number PV1602 14111008 PV1602 14127009 PV1609 14141018 - List of Teeth Whitening kits containing Relief ACP Oral Care Gel products distributed in U.S. SKU Number Lot Number ZM2665 14090044 ZM2665 14097026 ZM2665 14104024 ZM2665 14106004 ZM2665 14113035 ZM2665 14121018 ZM2665 14122005 ZM2665 14134020 ZM2666 14104025 ZM2666 14105025 ZM2666 14113028 ZM2666 14118015 ZM2666 14127019 ZM2666 14134030 ZM2666 14139005 DSH1001 14113006 DHS1001 14127007 List of Teeth Whitening kits containing Relief ACP Oral Care Gel products distributed outside of U.S.: SKU Number Lot Number ZME2665 14143017 ZME2665 14143024 ZME2631 14132015 ZME2645R 14153007 ZME2667 14147003 ZME2667 14132016 ZME2667 14141020 ZME2667 14143009 ZME2667 14164002 ZME2667 14169008 881056701531 14135016 881057001531 14135007
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.