Ambu Inc. recalls Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternative to a face mask for achieving and maintai…

Recall date

February 10, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1236-2016

FDA classification

Class II

Brand / firm

Ambu Inc.

Sold / distributed

Please see attached consignee list

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.