FDA Recall
Terminated
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.
Recall: Z-1236-2016
·
Initiated February 10, 2016
Recall
- Recall Number
- Z-1236-2016
- Event Number
- 73366
- Firm
- Ambu Inc.
- FEI Number
- 1121788
- Product Code
- BTO
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- February 10, 2016
- Posted
- March 24, 2016
- Terminated
- June 22, 2016
- Address
- 6230 Old Dobbin Ln, Ste 250, Columbia, MD, 21045-5955
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
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.
Action
Filed Safety Notice was sent via USPS Certified Mail to all customers on Dec 10,2015.
Distribution
Please see attached consignee list
Quantity
Total Numbers of unit distributed: 45990 pes (USA)