Events

Retiro De Equipo (Recall) de Fisher and Paykel Healthcare Catheter Mount

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 Fisher and Paykel Healthcare 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
    22085
  • Fecha de inicio del evento
    2017-10-17
  • 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 manufacturer is initiating a recall due to an increased rate of split tubing cuffs in catheter mounts manufactured on specific dates., a split tubing cuff on the catheter mount may potentially cause a leak which could lead to patient hypoxemia if undetected.
  • Acción
    Product to be destroyed

Device

Fisher and Paykel Healthcare Catheter Mount
  • Modelo / Serial
    Model: RT021, Affected: From Lot 2100089358 to Lot 2100098462 and from Lot 2100190360 to Lot 2100241254
  • Manufacturer
    Fisher and Paykel Healthcare Ltd

Manufacturer

Fisher and Paykel Healthcare Ltd