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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00886-1
Product Name/Description	Synthesis, Avant & Primo2x Families Adult Oxygenator Mounting Brackets (used with Sorin 3T Heater-Cooler devices) D632 Adult Open System Bracket Catalogue Number: 05046 Adult Oxy module Avant Bracket Catalogue Number: 050128 Synthesis “C” Bracket Catalogue Number: 050350 Synergy Bracket Catalogue Number: 050131 D626 Avant Holder Catalogue Number: 05040 D630 Avant Holder Catalogue Number: 05041 Synthesis Oxygenator Holder Catalogue Number: 050127 ARTG # 194514
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	13/07/2016
Responsible Entity	LivaNova Australia Pty Ltd
Reason/Issue	LivaNova (Sorin) have found that certain oxygenator mounting brackets that include tubing that connects the Heater-Cooler 3T water circuit to the oxygenator could be a source of re-contamination (with non-tuberculous mycobacteria) of a clean Heater-Cooler 3T’s water circuit. This tubing is not subjected to disinfection as per the IFU for the Heater-Cooler. If the Heater-Cooler 3T user failed to clean and disinfect the Heater-Cooler 3T resulting in contamination of the Heater-Cooler 3T and at some point later used oxygenator mounting bracket, the water from the contaminated Heater-Cooler 3T could cross-contaminate the Oxygenator mounting bracket’s internal tubing in which biofilm could develop. If a non-contaminated Heater-Cooler 3T was later connected to an Oxygenator mounting bracket that had been previously cross contaminated, the Oxygenator mounting bracket could contaminate the clean Heater-Cooler 3T.
Recall Action	Recall for Product Correction
Recall Action Instructions	LivaNova will replace the affected bracket and is providing advice to users on how to dispose of the affected Oxygenator bracket. The existing brackets can be used until a replacement unit can be provided. This action has been closed out on the 26/09/2018.
Contact Information	03 9799 7444 - LivaNova