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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00584-1
Product Name/Description	Endoscopic Curved Needle Driver, LapSac Introducer and LapSac Introducer Set Endoscopic Curved Needle Driver Catalogue Numbers: 096511, J-ENH-033100, J-ENH-053100, J-ENH-053120 and J-ENH-053130 ARTG Number: 212233 LapSac Introducer Catalogue Number: J-LSI-102500 ARTG Number: 276893 LapSac Introducer Set Catalogue Number: 054300 Previous ARTG Number: 276893 All Lots
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	9/05/2017
Responsible Entity	William A Cook Australia Pty Ltd
Reason/Issue	Cook Medical have identified that the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilisation of specific Endoscopic Curved Needle Driver, LapSac Introducer and LapSac Introducer Set products. Preliminary investigation indicates that validation data related to the reprocessing of these devices do not meet the current guidance. To date, the manufacturer has received no reports of adverse reactions related to inadequate cleaning, disinfection, or sterilisation associated with these devices. Potential adverse events that may occur if the products are not adequately reprocessed include localised surgical site infection, to deeper organ space infection, as well as chemical residual exposure.
Recall Action	Recall
Recall Action Instructions	Cook Medical is advising users to examine their inventory immediately to identify and quarantine any affected products. Products are to be discarded or returned to Cook Medical. This action has been reviewed and is considered complete in accordance with the requirements of the URPTG.
Contact Information	1800 777 222 - Cook Medical Customer Service