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TGA Action ID	RC-2025-RN-00691-1
Type of Product	Medical Device
Product Name/Description	Fortress Introducer Sheath System, 6F Straight 45cm Model Number: 386594 Lot Number: 800989 Manufacture Date: 22-Nov-2024 Expiry Date: 31-Oct-2027
ARTG Number	170253
Action Type	Recall
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	It has been identified that some units within Lot Number 800989 of the Fortress Introducer System, 6F Straight 45cm, have been packaged with an incorrect pouch label. Specifically, the Reference (REF) number, Unique Device Identifier - Device Identifier (UDI-DI), and device representation scheme are of the 4F version of the device, rather than the packaged 6F version. All other product details are correct on the packaging. There have been two complaints about this problem and no reports of adverse patient events. There is a potential risk of a bleeding complication as a 4French puncture hole is significantly smaller than a 6French access hole (1,2 mm vs 2 mm). In most cases, only the device traceability is compromised.
Instructions for Customers/Users	Customers are to: - Inspect stock for affected units. - Quarantine affected stock of Lot 800989. - Contact the local sales representative to arrange for return and replacement of the product. This action has been finalised on 11/9/2025.
Action Commencement Date	12/08/2025
Responsible Entity	Biotronik Australia Pty Ltd
Contact Information	02 9497 3700 - Biotronik Customer Care