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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00283-2
Product Name/Description	Renasys GO External Power Supply Units supplied with Renasys GO NPWT Pumps (Negative Pressure Wound Therapy System) Renasys GO External Power Unit Part Number: 66800161 Serial Numbers below 144500875 ARTG Number: 155594
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	15/03/2016
Responsible Entity	Smith & Nephew Pty Ltd
Reason/Issue	Smith & Nephew Pty Ltd. has identified a risk that some External Power Units have the potential to overheat and induce an electric shock whilst in use with the Renasys GO NPWT Pump. Only certain External Power Units are affected by this issue. To date there have been 2 reported adverse events related to this issue, including one electric shock – discomfort, and one minor burn.
Recall Action	Recall
Recall Action Instructions	Smith & Nephew is advising users to disconnect all affected power units from the mains electrical supply and switch to an unaffected power unit. The pump will continue to provide treatment as the device will run off its internal battery during this time. Affected units can be returned to Smith & Nephew and will be replaced with unaffected stock This action has been closed on the 14/09/2018.
Contact Information	02 9857 3999 - Smith & Nephew