Events

Recall of Flexi-Slip endotracheal tube stylets(Intended for use in facilitating intubation of tracheal tubes.)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Teleflex Medical 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-2015-RN-00874-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-09-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00874-1
  • 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 have been reports of the plastic coating of the stylet splitting and/or breaking off of the stylet. this may result in a piece of plastic totally or partially occluding the patient’s airway and impairing ventilation, or necessitating invasive removal procedures in order to prevent complications such as atelectasis or pneumonia. over 200,000 units have been distributed and there have been 4 complaints to august 2015. this gives rise to a complaint rate of 0.00205%.No patient injuries have been reported related to this issue.
  • Action
    Customers are asked to inspect their stock, quarantine any affected units from use and to follow the instructions on the acknowledgement form in order to have those units collected. An appropriate account credit will then be issued. This action has been closed-out on 22/08/2016.

Device

Flexi-Slip endotracheal tube stylets(Intended for use in facilitating intubation of tracheal tubes.)
  • Model / Serial
    Flexi-Slip endotracheal tube stylets(Intended for use in facilitating intubation of tracheal tubes.)SAP/Catalogue Number: 502501-000060Batch Numbers: 14BG27, 14FG03ARTG Number: 214058
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd