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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00183-1
Product Name/Description	Hemodialysis Monitor Catalogue number: HD03 Lot numbers: A81225, A91394 & B21812 ARTG number: 187558
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	19/03/2015
Responsible Entity	Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Reason/Issue	This recall is being initiated because of customer complaints indicating the inability to obtain measurements due to the device sometimes seeing no flow or irrelevant flow condition when used with patients during dialysis procedures. No reports of any injuries have been reported nor are expected due to the nature of this issue. The problem is readily identified to the user by a zero or a very low flow value displayed on HD03 and/or no measurements produced in other modes (recirculation; access flow; or cardiac output).
Recall Action	Recall
Recall Action Instructions	Emergo is advising their customers to discontinue the use of the monitor and contact Transonic customer service to arrange for replacement (repair/exchange) immediately. This action has been closed-out on 18/07/2016.
Contact Information	02 9006 1662 - Emergo Australia