Events

Rappel de Relief ACP Oral Care Gel

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Discus Dental LLC.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    69625
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0425-2015
  • Date de mise en oeuvre de l'événement
    2014-10-24
  • Date de publication de l'événement
    2014-11-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-04-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131193
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Varnish, cavity - Product Code LBH
  • Cause
    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.

Device

Relief ACP Oral Care Gel
  • Modèle / numéro de série
    - 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
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • 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.
  • Description du dispositif
    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
  • Manufacturer
    Discus Dental LLC

Manufacturer

Discus Dental LLC
  • Adresse du fabricant
    Discus Dental LLC, 1700 S Baker Ave Ste A, Ontario CA 91761-8081
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA