Events

Retiro De Equipo (Recall) de Atrium Thoracic Catheters

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 Atrium Medical Corporation.

¿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
    21131
  • Fecha de inicio del evento
    2017-02-22
  • 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: Maquet Australia Pty Ltd (NZ), 12G Andromeda Cres East Tamaki, Auckland 2013
  • Causa
    The manufacturer is providing clarification about the current labelling on two models of atrium thoracic catheters. the atrium thoracic catheters are packaged with a label containing an icon that depicts the product as having multiple eyelets. the graphical icon is designed to represent a generic thoracic catheter, and does not accurately reflect the actual eyelet configuration of the product contained in the package. the packaging is transparent allowing visualization of the actual number of eyelets on the thoracic catheter.
  • Acción
    Manufacturer to issue advice regarding use

Device

Atrium Thoracic Catheters
  • Modelo / Serial
    Model: , Affected: 8 Fr Thoracic Catheter code number 8008 All lot numbers, 10 Fr Thoracic Catheter code number 8010 All lot numbers
  • Manufacturer
    Atrium Medical Corporation

Manufacturer

Atrium Medical Corporation
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    NZMMDSA