Events

Rappel de Lunderquist Extra-Stiff Wire Guide

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par William A Cook Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00545-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-06-19
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00545-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.”.
  • Action
    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
  • Modèle / numéro de série
    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