Events

Recall of AMBU Ultraseal II Anaesthetic Mask

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-2018-RN-00799-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-06-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00799-1
  • 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
    Ambu australia has received reports regarding the potential for the ‘cushion seal to separate from the mask’. to date, there have been no adverse health consequences or medical interventions reported due to this issue.
  • Action
    AMBU is advising customers to inspect stock and quarantine all AMBU UltraSeal II Anaesthetic Masks. AMBU will arrange collection of all the affected masks

Device

AMBU Ultraseal II Anaesthetic Mask
  • Model / Serial
    AMBU Ultraseal II Anaesthetic MaskAll Sizes and Batch NumbersARTG Number: 200658 (AMBU Australia Pty Ltd - Anaesthesia face mask, non-scavenging, single-use)
  • Manufacturer
    AMBU Australia Pty Ltd

Manufacturer

AMBU Australia Pty Ltd