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TGA Action ID	RC-2026-RN-00606-1
Type of Product	Medical Device
Product Name/Description	POWERSEAL 5 MM (in diameter) 23 CM (long) Curved Jaw Sealer & Divider Model: PS-0523CJDA Lot Number: FR490902
ARTG Number	371990
Unique Device Identifier (UDI)	00821925044531
Action Type	Product Correction
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	Lot FR490902 may contain a labelling discrepancy. Specifically, the affected units were packaged in an outer shelf box labelled for a 37cm device versus an outer shelf box labelled for a 23cm device. However, other labelling on the outer shelf box, as well as the device and product cord label correctly identify the product as the 23cm device, which may result in customer confusion, a delay in initiating treatment, or prolongation of a procedure. All devices contained within Lot FR490902 are the correct 23cm length.
Instructions for Customers/Users	Customers are to: 1) Review inventory for the affected lot number. Discard the outer box and attach the customer letter to the inner device packaging. 2) Continue to use the device per the IFU. 3) Check the sterile packaging and device labels before use to ensure they are using the correct length for their procedure.
Action Commencement Date	11/08/2026
Responsible Entity	Olympus Australia Pty Ltd
Contact Information	1300 132 992 - Olympus Customer Operations