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TGA Action ID	RC-2026-RN-00007-1
Type of Product	Medical Device
Product Name/Description	da Vinci Single Port System Access Port Kits SP Access Port Small Incision Part Numbers: 430073 Lot Numbers: K10250522, K10250630, K10250828, K11250821, U10250108, U11241101, U11250219 SP Access Port Large Incision Part Number: 430075 Lot Numbers: U10250102, U10241107, U10250123, U10250219, K10250529, K10250605
ARTG Number	467226
Action Type	Recall
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	A subset of tray tubs may develop cracks due to a supplier manufacturing problem that caused localised thinning of the plastic during the forming process. Because the tray tub contributes to the sterile barrier, a crack may cause a sterility breach, resulting in the product no longer being sterile at the time of use. There have been no adverse events reported.
Instructions for Customers/Users	Customers are to: - Review stock and Quarantine affected inventory. - Complete and return the attached Customer Response Form immediately even if you do not have any affected devices. - If you identify affected stock, Device Technologies will be in contact with you to arrange their collection.
Action Commencement Date	6/01/2026
Responsible Entity	Device Technologies Australia Pty Ltd
Contact Information	1300 338 423 - Device Technologies