| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01240-1 |
| Product Name/Description |
Ambu AuraGain Single Use Laryngeal Mask – Sterile
Various Lot Numbers affected
ARTG Number: 220597 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall |
| Recall Action Instructions |
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. |
| Contact Information |
1300 233 118 |