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.
FDA Recall Z-1236-2016 · Posted 2016-03-24
Recalling FirmAmbu Inc.
Recall StatusTerminated
Product CodeBTO
Date Initiated2016-02-10
Date Terminated2016-06-22
Product QuantityTotal Numbers of unit distributed: 45990 pes (USA)
Reason for Recall
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.
Firm Action
Filed Safety Notice was sent via USPS Certified Mail to all customers on Dec 10,2015.
Root Cause
Process control
Distribution Pattern
Please see attached consignee list
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.