Events

Recall of Tracoe Twist Tracheostomy TubeSize 06

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Intersurgical 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-2017-RN-01321-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-10-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01321-1
  • 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
    Tracoe medical has established at primary packaging, that some obturators of one batch (size 06) can break when inserted into the outer cannula. this may result in the breakage of the obturator whilst in the patient within the tube. if this was to occur, the broken fragments would likely be inhaled into the lower respiratory tract.In the event the breakage of the obturator is not detected, the aspirated fragments may remain in the deep respiratory tract. should the fragments remain there over a longer period of time, in the worst case scenario, an inflammatory reaction in the respiratory tract can occur.
  • Action
    Intersurgical is advising users to quarantine affected stock. Intersurgical will collect stock from affected customers and provide credit.

Device

Tracoe Twist Tracheostomy TubeSize 06
  • Model / Serial
    Tracoe Twist Tracheostomy TubeSize 06Reference Number: REF 306-06Batch Numbers: 1000123766, 1000124104, and 1000124346 ARTG Number 128498 (Intersurgical Australia Pty Ltd - Tube, tracheostomy, single use)
  • Manufacturer
    Intersurgical Australia Pty Ltd

Manufacturer

Intersurgical Australia Pty Ltd