Events

Retiro De Equipo (Recall) de 3M ESPE Adper Single Bond 2

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por 3M 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-00132-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-02-03
  • 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-00132-1
  • 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
    3m australia is undertaking a recall for the affected batch as the outer pouches of the 3g vials have been incorrectly labelled as 6g. the product has been manufactured to specification and will work as intended.
  • Acción
    3M Australia is advising users to inspect stock and quarantine affected units. Affected stock will be replaced with unaffected product or a credit note issued. This action has been closed-out on 25/01/2016.

Device

3M ESPE Adper Single Bond 2
  • Modelo / Serial
    3M ESPE Adper Single Bond 2Catalogue Number: 51202Lot Number: N711552 Expiry Date: May 2018ARTG Number: 109870
  • Manufacturer
    3M Australia Pty Ltd

Manufacturer

3M Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    3m Company
  • Source
    DHTGA