Events

Recall of Neonate Resuscitator with Coded Airway & Filter Resuscitator Kit

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-2016-RN-00736-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-06-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00736-1
  • 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
    Teleflex is recalling the neonate resuscitator with coded airway & filter resuscitator kit, as the kit was found to contain an incorrect component. the kit should be packaged with a 50mm guedel airway. however, a twin port mask was packed in the kit instead. if a 50mm guedel airway is missing from the package, this may result in a delay of treatment/airway irritation due to sub-optimal size/compromised airway. given the patient population associated with the use of this device, a delay in resuscitation has the potential to lead to adverse health consequences.
  • Action
    Users are notified that on receipt of the acknowledgement form a return goods authorisation number will be issued and then a member of the Teleflex team will arrange collection of any affected stock from each facility. A credit will be applied to the customer account for stock returned as part of this recall. This action has been closed-out on 15/02/2017.

Device

Neonate Resuscitator with Coded Airway & Filter Resuscitator Kit
  • Model / Serial
    Neonate Resuscitator with Coded Airway & Filter Resuscitator KitCatalogue Number: 99424Batch Number: 201552ARTG Number: 226699
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd