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Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00526-1
Product Name/Description	Everest Bipolar Cutting Forceps Model number: 3005 Batch numbers: FR145203, FR204443, FR215012, FR246906, FR261731, FR296145, FR335650 ARTG 140374 (Olympus Australia Pty Ltd - Electrode, electrosurgical, active, foot-controlled, single use)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	27/06/2024
Responsible Entity	Olympus Australia Pty Ltd
Reason/Issue	Olympus has received 15 complaints globally indicating fractures and breakages in packaging trays and Tyvek covers which may lead to a sterility breach. Use of products with damaged trays where sterility may be compromised can lead to patient infection. Olympus has received no reports of adverse events related to the identified problem.
Recall Action	Recall
Recall Action Instructions	Customers are to quarantine products from the affected batch numbers, complete the reply form and once received, Olympus will reach out to organise a return and apply a credit.
Contact Information	1300 132 992 - Olympus Customer Operations