Events

Recall of Hudson Nebuliser Adaptor - AQUAPAK

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-2014-RN-01103-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-10-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01103-1
  • 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 medical has initiated this recall due to the possibility that the seals of the adaptor packaging may be creased which may potentially affect packaging integrity and the sterility of the adaptor.
  • Action
    Teleflex Medical is advising the customers to immediately discontinue use and quarantine all affected units. Teleflex Medical customer service will arrange for the collection and replacement of the affected units or provide a credit note. This acton has been closed-out on 02/05/2017.

Device

Hudson Nebuliser Adaptor - AQUAPAK
  • Model / Serial
    Hudson Nebuliser Adaptor - AQUAPAKProduct Codes: HUD403728, HUD404428Lot numbers: HUD403728 – 100130HUD404428 - 039134ARTG Number: 215829
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd