Print version of this report
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