Retiro De Equipo (Recall) de Unomedical Suction system tubing (sterile)

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Unomedical Sdn Bhd.

¿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
  • ID del evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Convatec (New Zealand) Ltd, WHK Gosling Chapman, Level 6, 51-53 Shortland Street, Auckland
  • Causa
    An internal assessment of product complaints has confirmed that these devices are not meeting the manufacturer's specifications. specifically, the connector part for application to the suction devices in these lots, has failed to meet its required durability. the connector parts of the specified lots have a higher probability to crack once applied to suction devices outlets.
  • Acción
    Product to be returned to supplier


  • Modelo / Serial
    Model: 530.25.200, 530.25.300, 530.25.450, 530.25.800, 530.30.200, 530.30.300, 530.30.600, 533.30.300, Affected: Selected lot numbers
  • Manufacturer