Recall Z-0109-2019— Besmed Health Business Corporation
Class II · Terminated
Class II FDA medical device recall by Besmed Health Business Corporation, initiated 2018-08-09, terminated 2019-05-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000. Reason: Ambu Aura40 Standard, Reusable Laryngeal Mask packaged in a pouch marked AuraStraight Silicone, Single Use Laryngeal Mask Sterile.
- Recalling firm
- Besmed Health Business Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-08-09
- Terminated
- 2019-05-10
- Firm location
- New Taipei City, N/A, Taiwan
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.