Recall Z-1236-2016— Ambu Inc.
Class II · Terminated
Class II FDA medical device recall by Ambu Inc., initiated 2016-02-10, terminated 2016-06-22. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. 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..
- Recalling firm
- Ambu Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-02-10
- Terminated
- 2016-06-22
- Firm location
- Columbia, MD, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.