Events

Recall of AQUAPAK BRITISH and INTL 340 SW, 340 ML W/040B Humidifier Adaptors

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-00138-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-03-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00138-1
  • 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 is recalling the products listed due to a possibility that the packages may contain foreign material, (predominantly synthetically derived pvc). this foreign matter has only been found in the package and not in the gas flow path of the humidifier product. if the foreign matter particles migrate into the sterile water reservoir, or enter the connecting tubing between the reservoir and the patient, the particle could potentially enter the patient airway at very high gas flows and could cause the hazard of mild lung discomfort, which is usually temporary and reversible.
  • Action
    A Teleflex representative will contact hospitals and medical centres to arrange for the affected devices to be inspected. Any units with foreign material will be recalled. If there is no visible foreign matter the product is safe to use. Unaffected batches are not expected to be available until May 2015. This action has been closed-out on 31/05/2016.

Device

AQUAPAK BRITISH and INTL 340 SW, 340 ML W/040B Humidifier Adaptors
  • Model / Serial
    AQUAPAK BRITISH and INTL 340 SW, 340 ML W/040B Humidifier AdaptorsCatalogue number: 400340 Batch Numbers: 149137, 307137, 362137, 385137Catalogue number: 003-40B Batch Numbers: 312137, 394137, 396137, 429137Catalogue Number: 400360 Batch Number: 91136ARTG Number: 215829
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd