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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00799-1
Product Name/Description AMBU Ultraseal II Anaesthetic Mask

All Sizes and Batch Numbers

ARTG Number: 200658
(AMBU Australia Pty Ltd - Anaesthesia face mask, non-scavenging, single-use)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 20/06/2018
Responsible Entity AMBU Australia Pty Ltd
Reason/Issue 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.
Recall Action Recall
Recall Action Instructions AMBU is advising customers to inspect stock and quarantine all AMBU UltraSeal II Anaesthetic Masks. AMBU will arrange collection of all the affected masks

This action has been closed out on 20/11/2020
Contact Information 1300 233 118 - AMBU Australia