Events

Retiro De Equipo (Recall) de System 6 Aseptic Battery Kit

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Stryker 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-2015-RN-00049-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-01-20
  • 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-2015-RN-00049-1
  • 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
    The system 6 aseptic battery kit provides a sterile enclosure for the styker non-sterile battery. the manufacturer has identified the affected lot to have insufficient bond strength at a weld joint associated with the aseptic housing, due to an issue during manufacture. therefore, the quality of the weld may not be as effective as intended. this could lead to the separation of the top section of the housing from the bottom section. this may lead to sterility breaches, loss of surgical control, intra-operative complications and potential delays in surgery.
  • Acción
    Affected units will be replaced via the standard stock replenishment process. This action has been closed-out on 18/08/2016.

Device

System 6 Aseptic Battery Kit

Manufacturer

Stryker Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA