Events

Recall of Renasys GO External Power Supply Units supplied with Renasys GO NPWT Pumps (Negative Pressure Wound Therapy System)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Smith & Nephew Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-00283-2
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00283-2
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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.

Device

Renasys GO External Power Supply Units supplied with Renasys GO NPWT Pumps (Negative Pressure Wou...
  • Model / Serial
    Renasys GO External Power Supply Units supplied with Renasys GO NPWT Pumps (Negative Pressure Wound Therapy System)Renasys GO External Power UnitPart Number: 66800161 Serial Numbers below 144500875ARTG Number: 155594
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd