Events

Retiro De Equipo (Recall) de Various Sage Oral Care Products

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Teleflex Medical 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-2017-RN-01172-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-09-11
  • 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-2017-RN-01172-1
  • 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
    Teleflex medical australia has been advised by the manufacturer sage products llc that there is the potential for cross-contamination of specific oral care solutions manufactured by a third party supplier on equipment shared with non-pharmaceutical products. the affects all oral care products containing solutions manufactured by the third party supplier. the affected products were distributed between july 2015 and august 2017.
  • Acción
    1. Discontinue use and/or further distribution of the affected lots. 2. Immediately quarantine any affected stock and complete the supplied acknowledgement form and email to austcs@teleflex.com 3. Destroy or dispose of affected product and provide records to Teleflex on the supplied acknowledgment form. 4. Complete the supplied recall acknowledgement form and return it to Teleflex. This form must be completed even if you no longer have affected product.

Device

Various Sage Oral Care Products

Manufacturer

Teleflex Medical Australia Pty Ltd