Events

Recall of Back Table Cover supplied in a limited range of Operating Room Packs

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Plus Medical 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-2015-RN-00686-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-07-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00686-1
  • 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
    Itl healthcare has identified an issue as a result of one customer complaint with the standard back table cover from one supplier. once the outer bag is opened the back table cover serves as a trolley cover. in some instances the sterility will be breached if the permeability of the back table cover is challenged. this issue was not observed in all batches; the extent is still under investigation.
  • Action
    ITL Healthcare is providing workaround instructions to be undertaken during surgery setup. Alternative Back Table Covers will be provided free of charge to facilitate the workaround. Should the hospital be unable to implement the workaround, ITL will provide replacement Operating Room Packs. This action has been closed-out on 15/08/2016.

Device

Back Table Cover supplied in a limited range of Operating Room Packs
  • Model / Serial
    Back Table Cover supplied in a limited range of Operating Room Packs
  • Manufacturer
    Plus Medical Pty Ltd

Manufacturer

Plus Medical Pty Ltd