Class 2 Device Recall Relief ACP Oral Care Gel

• Date Initiated by Firm: October 24, 2014
• Date Posted: November 24, 2014
• Recall Status: Terminated on April 14, 2015
• Recall Number: Z-0425-2015
• Recall Event ID: 69625
• 510(K)Number: K062176
• Product Classification: Varnish, cavity - Product Code LBH
• Product: 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
• Code Information: - 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
• Recalling Firm/ Manufacturer: Discus Dental LLC; 1700 S Baker Ave Ste A; Ontario CA 91761-8081
• For Additional Information Contact: 909-570-3500
• Manufacturer 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.
• FDA Determined 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. Please use Attachment A: Product Shipped, Acknowledgement and Response Form to document the quantity of affected lots of product being returned to Discus Dental LLC. Go to www.philips.com/discus-reliefgel and enter the requested information with contact details. 3. Please contact Discus Dental customer service at CustomerServicePhone if you have any questions and to arrange for replacement products and prepaid return shipping label.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LBH and Original Applicant = DISCUS DENTAL INC.