Retiro De Equipo (Recall) de Basin Liner within Molnlycke ProcedurePak (surgical procedure packs)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Molnlycke Health Care 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-01042-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-10-24
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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
    During standard quality checking of components for use within molnycke health care procedurepak it has been found that some units of the basin liners provided in the pack have small holes in them which could be undetectable in normal use.
  • Acción
    Molnlycke Health Care is requesting their customers to remove the affected basin liner from the pack once the pack is opened for surgery. A sterile bowl should be used in place of the liner.

Device

  • Modelo / Serial
    Basin Liner within Molnlycke ProcedurePak (surgical procedure packs)ARTG entries: 133559, 133562, 133564, 133565
  • Manufacturer

Manufacturer