Events

Retiro De Equipo (Recall) de Receptal 1000 mL liner and canister used with the Laerdal Suction Unit

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Laerdal 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-00440-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-05-17
  • 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-00440-1
  • 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
    Laerdal has advised that the following situations can result in loss of suction:1. the hard canister and the single use liner are not properly seated;2. the liner separates from the canister during use.
  • Acción
    Laerdal are requesting their customers to immediately seek an alternative to the 1000 mL Receptal system. Laerdal recommend to only discontinue use of the suction liners and canister once an alternative is sourced. Once an alternative has been sourced the 1000 mL Receptal liners and canister should be discarded.

Device

Receptal 1000 mL liner and canister used with the Laerdal Suction Unit
  • Modelo / Serial
    Receptal 1000 mL liner and canister used with the Laerdal Suction UnitItem code: 78001033ARTG Number: 129688
  • Manufacturer
    Laerdal Pty Ltd

Manufacturer

Laerdal Pty Ltd