Device product
Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000
Z-0109-2019
Product summary
- Event
- Event 81009
- Status
- Terminated
- Classification
- Class II
- Quantity
- 267 units
- Official record key
device-enforcement:Z-0109-2019
Official wording
Reason: Ambu Aura40 Standard, Reusable Laryngeal Mask packaged in a pouch marked AuraStraight Silicone, Single Use Laryngeal Mask Sterile
Code information: Lot Numbers: MO0612G40021 and MO0605G40014
Distribution pattern: US Nationwide, and country of Canada.
Derived failure modes
-
Unknown
Ambu Aura40 Standard, Reusable Laryngeal Mask packaged in a pouch marked AuraStraight Silicone, Single Use Laryngeal Mask Sterile