Events

Retiro De Equipo (Recall) de Relief ACP Oral Care Gel

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Discus Dental LLC.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    69625
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0425-2015
  • Fecha de inicio del evento
    2014-10-24
  • Fecha de publicación del evento
    2014-11-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-04-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131193
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Varnish, cavity - Product Code LBH
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    - 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
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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
  • Dirección del fabricante
    Discus Dental LLC, 1700 S Baker Ave Ste A, Ontario CA 91761-8081
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA