Recall Z-1236-2016 ยท BTO Tube, Tracheostomy (W/Wo Connector)
Ambu Inc.
Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternative to a face mask for achieving and maintaining control of the airway during routine emergency anesthetic procedures.
| Date | Mar 24, 2016 (initiated Feb 10, 2016) |
| Status | Terminated |
| Reason | Ambu, Aura Gain laryngeal Mask, was found to have lack of Sterility Assurance. The firm discovered the problem during final quality control at manufacturing site. Damage to the sterile barrier (the pouch) may compromise a medical device's sterility,leading to contamination of the product and,ultimately,patient complications. |
| Root cause | Process control |
| Action | Filed Safety Notice was sent via USPS Certified Mail to all customers on Dec 10,2015. |
| Quantity | Total Numbers of unit distributed: 45990 pes (USA) |
| Distribution | Please see attached consignee list |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.