Events

Retiro De Equipo (Recall) de Relief ACP Oral Care Gel supplied separately and in Zm CH 25% KitsRelief ACP 6-Syr w/Tray Case Dom

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Discus Dental Australia Pty Ltd.

¿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
    RC-2014-RN-01166-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-10-31
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01166-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Discus dental has become aware that one batch of relief acp oral care gel was filled with a teeth whitening gel (6%hydrogen peroxide as used) in one side of double barrel syringe instead of the intended component (phosphate gel). this was due to the ingredients being mislabelled after compounding the bulk components. this lot of relief acp oral care gel was also included in teeth whitening product kits.Br /br /further information can be found on the tga website at http://www.Tga.Gov.Au/alert/relief-acp-oral-care-gel.
  • Acción
    Philips is requesting dentists to immediately contact their patients who have provided with the affected product and advise them to immediately stop usage of the product. Dentists are also requested to discard any remaining affected product. Philips is providing replacement product at no cost to dentists/patients. This action has been closed-out on 04/04/2017.

Device

Relief ACP Oral Care Gel supplied separately and in Zm CH 25% KitsRelief ACP 6-Syr w/Tray Case Dom
  • Modelo / Serial
    Relief ACP Oral Care Gel supplied separately and in Zm CH 25% KitsRelief ACP 6-Syr w/Tray Case DomProduct number: PV1609Lot number: 14127003Relief ACP Bulk 24 Sngl SyrProduct number: PV1620Lot number: 14141018Zm CH 25% Kit DW 9.5% ACPF 2pk AZProduct number: 881056701531Lot number: 14135016Zm CH Kit No TU 2pk AZProduct number: 881057001531Lot number:14135007Zm CH 25% Kit DW 6% HP TU 2pk AZProduct number: 881067501531Lot number: 14097075ARTG: 219029
  • Manufacturer
    Discus Dental Australia Pty Ltd

Manufacturer

Discus Dental Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA