Events

Recall of ClinActiv and ClinActiv Plus Therapy Surface (used to provide pressure relief to aid in the prevention and treatment of pressure ulcers)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Hill-Rom 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-2013-RN-01108-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-11-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01108-1
  • 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
    Hill-rom has become aware of a possible hazardous situation when silicon oil contained in the vario sensor within the clinactiv therapy surface is accidentally released. when the pocket of silicone oil is subjected to excessive mechanical stress, it may disconnect and leak oil outside the mattress enclosure and onto the floor.
  • Action
    Hill-Rom is providing additional cleaning instructions on cleaning silicon oil from affected surfaces, and advising users to ensure the Vario sensor is replaced every 3 years. This action has been close-out on 11/02/2016.

Device

ClinActiv and ClinActiv Plus Therapy Surface (used to provide pressure relief to aid in the preve...
  • Model / Serial
    ClinActiv and ClinActiv Plus Therapy Surface (used to provide pressure relief to aid in the prevention and treatment of pressure ulcers)Model Number: N02050, N02051, P02062, P02063, P02064, P02065All Serial Numbers affectedARTG Number: 130272
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd