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.
- Company
- Ambu Inc.
- Recall Initiated
- February 10, 2016
- Posted
- March 24, 2016
- Terminated
- June 22, 2016
- Recall Number
- Z-1236-2016
- Quantity
- Total Numbers of unit distributed: 45990 pes (USA)
- Firm Location
- Columbia, MD
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.
Distribution
Please see attached consignee list
Lot / Code Info
Catalog Number:408300000 Size #3:All lots from 1632796 through lot number 1808911except lot number 1779966,1782239, 1795914 Catalog Number: 408400000 Size #4 All lots from 1632799 through lot number 1790075. Catalog Number:408500000 Size #5 All lots from 1632802 through lot number 1810863.
Root Cause
Process control
Action Taken
Filed Safety Notice was sent via USPS Certified Mail to all customers on Dec 10,2015.