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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