FDA recall Z-0109-2019
Besmed Health Business Corporation · Class II · device
Product
Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000
Reason for recall
Ambu Aura40 Standard, Reusable Laryngeal Mask packaged in a pouch marked AuraStraight Silicone, Single Use Laryngeal Mask Sterile
Distribution
US Nationwide, and country of Canada.
Key facts
- Status
- Terminated
- Initiation date
- 2018-08-09
- Report date
- 2018-10-24
- Termination date
- 2019-05-10
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- New Taipei City, N/A, Taiwan
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0109-2019