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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00545-1
Product Name/Description Lunderquist Extra-Stiff Wire Guide

Catalogue Numbers: TSCMG-35-260-7-LES

Lot Numbers: The following Lot number ONLY is impacted by this field action: E3307556

ARTG Number: 147635
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 19/06/2015
Responsible Entity William A Cook Australia Pty Ltd
Reason/Issue 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.”
Recall Action Recall
Recall Action Instructions 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.
Contact Information 1800 777 222 Cook Medical