Events

Recall of Ambu AuraGain Single Use Laryngeal Mask – Sterile

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by AMBU 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-01240-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-12-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01240-1
  • 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
    A failure has been discovered during routine quality control at the manufacturing site. this failure may cause a small hole (approximately 0.5mm) in the pouch of the device leading to a potential compromised sterile barrier.It has been estimated that this failure mode occurs in 3% of the affected lots. ambu has not received any complaints or other market feedback on the matter, dating from when the products were marketed in 2014.
  • Action
    AMBU is advising users to inspect stock and quarantine the affected units prior to their return to the sponsor. This action has been closed-out on 31/08/2016.

Device

Ambu AuraGain Single Use Laryngeal Mask – Sterile
  • Model / Serial
    Ambu AuraGain Single Use Laryngeal Mask – SterileVarious Lot Numbers affectedARTG Number: 220597
  • Manufacturer
    AMBU Australia Pty Ltd

Manufacturer

AMBU Australia Pty Ltd