Recall Z-0109-2019 ยท CAE Airway, Oropharyngeal, Anesthesiology
Besmed Health Business Corporation
Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000
| Date | Aug 9, 2018 |
| Status | Terminated |
| Reason | Ambu Aura40 Standard, Reusable Laryngeal Mask packaged in a pouch marked AuraStraight Silicone, Single Use Laryngeal Mask Sterile |
| Root cause | Error in labeling |
| Action | Ambu issued via USPS Certified Mail/Email to customers on Aug 09, 2018 advising users of the problem. If you have affected lot in stock and you are using it as Reusable Laryngeal Mask (following accompanying instruction for use), you can continue to use it and no need to return it. Accounts requested to see if you have affected lots in stock. If you do have it, check Aura40 Standard devices for incorrect labelled pouch, and place wrongly labelled products in quarantine. For collection and replacement by Ambu..Furthermore, please instruct all customers of the received LOT(s), to check their de |
| Quantity | 267 units |
| Distribution | US Nationwide, and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.