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TGA Action ID	RC-2026-RN-00594-1
Type of Product	Medical Device
Product Name/Description	StrykeFlow PS and AHTO Tube Sets Strykeflow PS Suction Irrigator Single Spike Tube Set Catalogue Number: 0250070530 Lot Numbers: 24260FG2, 24261FG2, 24298FG2, 24299FG2, 24302FG2, 24341FG2, 25008FG2, 25010FG2, 25011FG2, 25024FG2, 25034FG2, 25092FG2, 25182FG2, 25183FG2, 25216FG2, 24297FG2, 25035FG2, 25063FG2, 25064FG2, 25093FG2 AHTO Suction Irrigation Dual Spike Tube Set Catalogue Number: 0250070640 Lot Numbers: 24289FG2, 24338FG2, 25009FG2, 25091FG2
ARTG Number	207650
Action Type	Recall
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	There has been an increase in reported complaints describing leaking from the device during use. During use, the device may experience fluid leakage from the handpiece, which may result in fluid accumulating on the floor. For the AHTO tube sets, saline may react with internal copper wiring, resulting in the release of vaporised saline that may resemble smoke. The potential impacts include user inconvenience, short procedural delays, skin, eye or mucosal membrane irritation, contamination of the surgical field, perceptions of burning, and an increased risk of slip and fall incidents.
Instructions for Customers/Users	Customers are to: 1. Quarantine any affected product. 2. Contact their local Stryker representative to coordinate the return and replacement of any affected product.
Action Commencement Date	7/08/2026
Responsible Entity	Stryker Australia Pty Ltd
Contact Information	postmarketssp@stryker.com - Stryker