Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00092-1
Product Name/Description	Epix Universal Clip Applier Multiple product codes and batches ARTG 221008 (Applied Medical Australia Ply Ltd - Clip, internal, ligating)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	5/02/2024
Responsible Entity	Applied Medical Australia Pty Ltd
Reason/Issue	A nonconformance may result in a clip not loading into the jaws after the trigger is actuated for specific lot numbers of the Epix Universal Clip Applier If the clip applier is actuated on a vessel or structure with no clip in the jaws it may result in bleeding or further aggravation of bleeding vessels requiring unexpected medical intervention. Verifying that the clip has been properly positioned in the jaws may mitigate the potential associated risks. Applied Medical has implemented corrections in our manufacturing process to mitigate the nonconformance moving forward.
Recall Action	Recall
Recall Action Instructions	Customers should check inventory and quarantine affected stock on hand. Following receipt of a completed Customer Recall Notification Confirmation Form, Applied Medical will arrange product return and applicable replacement or credit.
Contact Information	1800 666 272 - Customer Relations