Z-0109-2019 Class II Terminated
FDA device recall Z-0109-2019 was initiated by Besmed Health Business Corporation on August 9, 2018 and is designated Class II. Reason for recall: Ambu Aura40 Standard, Reusable Laryngeal Mask packaged in a pouch marked AuraStraight Silicone, Single Use Laryngeal Mask Sterile The recall status is terminated (terminated May 10, 2019). Affected quantity: 267 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 24, 2018
- Initiation Date
- August 9, 2018
- Termination Date
- May 10, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 267 units
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
Distribution Pattern
US Nationwide, and country of Canada.
Code Information
Lot Numbers: MO0612G40021 and MO0605G40014