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Ambu Inc. recalls Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternative to a face mask for achieving and mainta
Recalled March 30, 2016 · FDA recall Z-1236-2016 · Ambu
Hazard
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. · FDA Class II
Units
Total Numbers of unit distributed: 45990 pes (USA)
Sold at
Please see attached consignee list
Description
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.
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.
Manufacturer(s)
Ambu Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →