Events

Retiro De Equipo (Recall) de Suction Adapter Type A (Gauge)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Xcel Medical Solutions 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-00929-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-09-16
  • 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-2015-RN-00929-1
  • 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 manufacturer has become aware that the affected connector may have a defective limit pin on the on-off lever, which would cause the pin to stick to the groove on the back of the on-off lever. this may result in the lever to break, resulting being unable to turn on or off the valve.This recall was undertaken prior to approval by the tga.
  • Acción
    Xcel Medical Solutions is requesting users to quaratine affected stock and return to Xcel Medical Solutions for replacement or full refund.

Device

Suction Adapter Type A (Gauge)
  • Modelo / Serial
    Suction Adapter Type A (Gauge)Reference Number: X05101Lot Number: Z141203ARTG Number: 194212
  • Manufacturer
    Xcel Medical Solutions Pty Ltd

Manufacturer

Xcel Medical Solutions Pty Ltd
  • Source
    DHTGA