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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00877-1
Product Name/Description	Transpac Monitoring Kits Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount Item Number: 011-46104-42 Lot Numbers: 2841944, 2841945, 2859326, 2865873 & 2869445 Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP Item Number: 011-46106-72 Lot Numbers: 2841690, 2841691 & 2859331 ARTG Number: 206780
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	8/08/2014
Responsible Entity	ICU Medical Australia Pty Ltd
Reason/Issue	ICU Medical has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. A leaking luer may have the potential effect of blood leakage or air embolism which may be life threatening or cause permanent severe injury or illness to the patient. There have been no reports of patient injury due to this problem.
Recall Action	Recall
Recall Action Instructions	ICU Medical Australia Pty Ltd is requesting their customers to inspect their stocks and quarantine all units from the affected lots. This action has been closed-out on 03/06/2016.
Contact Information	02 9629 6977 - ICU Medical Australia