Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternative to a face mask for achieving and maintain
FDA device recall Z-1236-2016 · posted 2016-03-24 · Terminated
Recall details
- Recalling firm
- Ambu Inc.
- 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.
- Action taken
- Filed Safety Notice was sent via USPS Certified Mail to all customers on Dec 10,2015.
- Root cause
- Process control
- Status
- Terminated
- Product code
- BTO
- Quantity affected
- Total Numbers of unit distributed: 45990 pes (USA)
- Distribution
- Please see attached consignee list
- Date initiated
- 2016-02-10
- Date posted
- 2016-03-24
- Date terminated
- 2016-06-22
- Location
- Columbia, MD
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