Events

Retiro De Equipo (Recall) de Lunderquist Extra-Stiff Wire Guide

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por William A Cook Australia 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-2015-RN-00545-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-06-19
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00545-1
  • 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
    Cook medical has received 3 reports of products with the product label indicating the wire guide is curved (the letter “c” in the prefix tscmg- stands for curved), however actual product inside package is a straight wire guide.This observation was made prior to use of the product as the physician is able to see the wire is not curved. the instructions for use (ifu) state “upon removal from package, inspect the product to ensure no damage has occurred.”.
  • Acción
    Hospitals are requested to immediately collect and return all unused affected products to Cook Medical for credit. This action has been closed-out on 12/08/2016.

Device

Lunderquist Extra-Stiff Wire Guide
  • Modelo / Serial
    Lunderquist Extra-Stiff Wire GuideCatalogue Numbers: TSCMG-35-260-7-LESLot Numbers: The following Lot number ONLY is impacted by this field action: E3307556ARTG Number: 147635
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd