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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00387-1
Product Name/Description	10mm Direct Drive Clip Applier (Used for ligation of tubular structures or vessels in laparoscopic and general surgical procedures) Product Code: CA090 Affected Lot Numbers: 1190181 to 1265006 Expiry date: Prior to 18 March 2019 Affected Kit Product Codes: CK304, GK306, GK307, GK311, GK312, GK317, GK318, GK323, GK334, GK335, K0509 and K0592 ARTG Number: 221008
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	5/04/2016
Responsible Entity	Applied Medical Australia Pty Ltd
Reason/Issue	Due to inconsistent clip application, the 10mm Direct Drive Clip Applier is being recalled. Although malformed clips are typically readily apparent to the user, this failure mode may lead to unoccluded vessels.
Recall Action	Recall
Recall Action Instructions	Applied Medical is advising users to check inventory for the affected lots and return any affected product. This action has been closed-out on 30/01/2017.
Contact Information	07 3853 2100 - Applied Medical - Customer Relations