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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-01269-1
Product Name/Description	Infinity Dual Hemo MCable Pod used with the Infinity Acute Care System (IACS) Monitoring Solution Dual Hemo MCable Pods with Revision Index RI15 and RI16 Manufactured between August 2015 to August 2016 ARTG Number: 138056
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	4/10/2017
Responsible Entity	Draeger Australia Pty Ltd
Reason/Issue	Dräger has determined through internal testing that Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Dräger Infinity Acute Care System, may permit liquid ingress inconsistent with their IPX4 rating, which could potentially result in an incorrect measured value of invasive blood pressure. Dräger has not received any complaints and is not aware of any negative patient consequences arising from this issue. Revisions prior to RI 15 and after RI17 continue to meet the IPX4 standard.
Recall Action	Recall for Product Correction
Recall Action Instructions	Dräger are advising users to inspect systems to identify any affected products. Dräger will be providing customers with a sleeve to apply in order to prevent the issue from occurring. This action has been closed out on the 09/10/2018.
Contact Information	03 9244 7248 - Draeger Medical Australia