Events

Retiro De Equipo (Recall) de Feather Touch Vinyl Examination Gloves

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Pro-Pac Packaging Aust 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-2016-RN-01292-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-09-30
  • 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-2016-RN-01292-1
  • 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
    It has been found that feather touch vinyl examination gloves are not suitable for medical/biological applications because they do not provide an effective barrier suitable for medical or biological protection.
  • Acción
    Pro-Pac Packaging is advising retailers and distributors to immediately quarantine all Feather Touch Vinyl Examination Gloves with ARTG # 160255 printed on the box, and to contact Pro-Pac who will arrange for the stock to be recovered and replacement stock, or a credit note to be issued. This action has been closed-out on 18/05/2017.

Device

Feather Touch Vinyl Examination Gloves

Manufacturer

Pro-Pac Packaging Aust Pty Ltd
  • Source
    DHTGA