Events

Retiro De Equipo (Recall) de LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier (metal ligating clip applier)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical 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-2013-RN-00396-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-05-01
  • 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-2013-RN-00396-1
  • 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
    Johnson & johnson pty ltd has identified potential clip formation and feeding issues, which may result in improper clip formation and insufficient occlusion of the vessel or other structure.
  • Acción
    End users are requested to immediately check their inventory to determine if their facility holds any affected units. Affected units must be quarantined until returned to Johnson & Johnson Pty Ltd.

Device

LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier (metal ligating clip applier)
  • Modelo / Serial
    LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier (metal ligating clip applier) Product Code: ER320Expiration Date: 2016-11 to 2018-03Kits containing ER320 Multiple kit product numbers and descriptions ARTG Number: 122810
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd