| 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 |
|
| 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 |