Events

Recall of ELS Cannulae (Part of intravenous catheterisation kit)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Maquet 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-2012-RN-01294-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2012-12-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01294-1
  • 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
    There is a chance that specific lots of the the els 15 fr cannula could have a partially occluded arterial lumen.
  • Action
    Maquet Australia is recalling and replacing the affected unit. This action has been closed-out on 29/01/2016.

Device

ELS Cannulae (Part of intravenous catheterisation kit)
  • Model / Serial
    ELS Cannulae (Part of intravenous catheterisation kit)Catalogue Number: M-1510Lot Number: 92065588ARTG Number: 172670
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    DHTGA