Events

Recall of Lunderquist Extra-Stiff Wire Guide

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by William A Cook Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-00545-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00545-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / 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