Events

Recall of Neptune 2 Rover Ultra (Mobile unit used as surgical fluid/smoke waste management system)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker Australia 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-2014-RN-00139-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-02-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00139-1
  • 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
    Stryker is implementing upgrades to the neptune 2 waste management system further to the previous recall for product correction in may 2013 (tga reference: rc-2013-rn-00265-1) where stryker received reports of serious injury or death in the usa due to the neptune 2 being connected to a passive chest drainage tube or closed wound drainage device post-operatively.
  • Action
    Stryker is upgrading the Neptune 2 Rover Ultra units with a new top cap, labels and software package to mitigate the potential for incorrect use. Thia action has been closed-out on 28/01/2016.

Device

Neptune 2 Rover Ultra (Mobile unit used as surgical fluid/smoke waste management system)

Manufacturer

Stryker Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA