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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-01232-1
Product Name/Description	Medfusion 4000 Syringe Infusion Pump All lot numbers affected ARTG Number: 122405
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	21/11/2013
Responsible Entity	Smiths Medical Australasia Pty Ltd
Reason/Issue	Smiths Medical has identified an issue with electrical shorting at the AC power receptacle. Shorting can occur when saline solution or other conductive fluids (e.g., potassium chloride) enter the AC power receptacle. When this happens, sparking and/ or flames, accompanied by smoke, may appear at the AC power receptacle. The pump and the AC power cord are constructed of flame retardant materials; therefore, the sparks/ flames extinguish within seconds. There is a potential for delay in treatment while a replacement or alternative method of delivery is obtained.
Recall Action	Recall for Product Correction
Recall Action Instructions	Smiths Medical is advising users to immediately unplug the AC power cord from the power source if there are signs of sparking, flames or smoke emitting from the unit. Smiths Medical is providing work around instructions for users to follow until Smiths Medical develops a permanent fix.
Contact Information	1800 654 949 - Smith's Medical Customer Service Department