Recall Z-0425-2015 ยท LBH Varnish, Cavity
Discus Dental LLC
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
| Date | Nov 24, 2014 (initiated Oct 24, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Mixed-up of materials/components |
| Action | Cease distribution of the product immediately and contact patients who may have received the product from April 1, 2014. Patients who are still in possession of Relief ACP Oral Care Gel should return affected product to dentinal office. Discus Dental is offering a non-cost replacement for all affected product, including free shipping. To remedy the situation take the following steps: 1. Contact the patients who have received affected product after April 1, 2014 either by letter or telephone, and instruct them to cease use of the product immediately and return any remaining product. 2. Ple |
| Quantity | 20,251 distributed in U.S. on nationwide level and 14,653 internationally |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062176 | RELIEF ACP ORAL CARE GEL Discus Dental, Inc., Jan 10, 2007 |