Events

Retiro De Equipo (Recall) de WECK Visistat 35R Disposable Skin Stapler

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-00508-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-04-20
  • 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-00508-1
  • 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
    For a single product lot, teleflex medical has identified a labelling error on the boxes which contain six individually packaged and labelled device units. some boxes are labelled as containing visistat wide devices, when they in fact contain visistat regular devices. the individual units are correctly labelled with the actual size of the device. the labelling error applies only to some units of sales boxes in the affected lot number. it is unlikely that the use of these products will result in any adverse health consequences, although it is possible there could be a delay of the procedure.
  • Acción
    Teleflex is advising users of the labelling error, and requesting that they place a copy of the customer letter detailing the issue with the affected lot.

Device

WECK Visistat 35R Disposable Skin Stapler

Manufacturer

Teleflex Medical Australia Pty Ltd