BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-0425-2015 · Initiated October 24, 2014

    Recall

    Recall Number
    Z-0425-2015
    Event Number
    69625
    Firm
    Discus Dental LLC
    FEI Number
    1000582314
    Product Code
    LBH
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    October 24, 2014
    Posted
    November 24, 2014
    Terminated
    April 14, 2015
    Address
    1700 S Baker Ave, Ste A, Ontario, CA, 91761-8081

    Description

    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

    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.

    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.

    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