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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00091-2
Product Name/Description	Level 1 Fast Flow Fluid Warmers with and without Air Detection Item Code: H-1200 Affected Serial Numbers: S103A00028, S103A00029, S103A00094 and S103A00095 ARTG Number: 108420
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	31/01/2013
Responsible Entity	Smiths Medical Australasia Pty Ltd
Reason/Issue	A limited number of fluid warmers were manufactured with an incorrect printed circuit board component which could prevent the fluid warmer from functioning as intended and also potentially exhibiting a false over temperature alarm.
Recall Action	Recall for Product Correction
Recall Action Instructions	Smiths Medical Australasia is requesting users to identify any affected units and place in quarantine. A Biomedical Technician will inspect devices to determine if they are affected and provide a correction.
Contact Information	1800 654 949 - Smiths Medical Customer Service Department