Events

Retiro De Equipo (Recall) de Supergloves Vinyl Examination Gloves, powdered & powder free

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Supergloves 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-2016-RN-01481-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-11-16
  • 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-01481-1
  • 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
    Testing by the tga has found that supergloves 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
    Supergloves Australia Pty Ltd is advising all customers & distributors to quarantine all Supergloves Vinyl Examination Gloves with ARTG # 196064 printed on the box and to contact Supergloves who will arrange for the stocks to be recovered and a credit note issued. This action has been closed-out on 23/05/2017.

Device

Supergloves Vinyl Examination Gloves, powdered & powder free
  • Modelo / Serial
    Supergloves Vinyl Examination Gloves, powdered & powder freeAll batchesARTG Number: 196064
  • Manufacturer
    Supergloves Australia Pty Ltd

Manufacturer

Supergloves Australia Pty Ltd
  • Source
    DHTGA