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TGA Action ID	RC-2026-RN-00234-1
Type of Product	Medical Device
Product Name/Description	Microbore Trifuse Extension Sets Extension Set, Adaptor, Trifuse Microbore, H-Port x3, 7.5 cm Lot Numbers: 212142KS, 214439KS, 215454KS, 215259KS, 217125KS, 217284KS Extension Set, Adaptor, Trifuse Microbore, nPulse x3, Removable Slide Clamp x3, 7.5 cm Lot Number: 215450KS, 217158KS
ARTG Number	164119
Action Type	Recall
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	ICU Medical Australia has identified a lot-specific problem with the central adaptor component on some Microbore Trifuse Extension Sets. These lots have the potential to crack during use, which may result in fluid leaks, leading to under delivery of drugs and delay or interruption in therapy. To date, ICU Medical Australia has not received any reports of serious injury or death relating to this problem.
Instructions for Customers/Users	Customers are to: - Inspect inventory and quarantine affected lots to prevent further use. - Destroy all affected products. ICU Medical will process credits for impacted stock.
Action Commencement Date	2/04/2026
Responsible Entity	ICU Medical Australia Pty Ltd
Contact Information	1300 428 652 - ICU Medical Customer Service