Events

Retiro De Equipo (Recall) de Medela Breast Pump Powered - Detachable Wall Plug

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 Medela AG.

¿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
    20526
  • Fecha de inicio del evento
    2016-08-19
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 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: Fisher and Paykel Healthcare Ltd, 15 Maurice Paykel Place, East Tamaki, AUCKLAND 2013
  • Causa
    The unit is composed of two parts: (1) a detachable wall plug; and (2) the power adapter itself, with cord attached., there are three versions of the wall plug. only one is affected. in rare cases, one version of the detachable wall plug supplied with the medela breastpump could split exposing a live wire and creating a risk of electrick shock.
  • Acción
    Product to be returned to supplier

Device

Medela Breast Pump Powered - Detachable Wall Plug
  • Modelo / Serial
    Model: 099 0273; 099.0018 (AC Power Adapter) 040.0011; 040.0011-1; 042.0014; 030.0040; 030.0040-1; (Breast Pumps), Affected:
  • Manufacturer
    Medela AG

Manufacturer

Medela AG