Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile recall: Sterility Concern
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…
Why was Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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…
- Recalling firm
- Ambu Inc.
- Quantity
- Total Numbers of unit distributed: 45990 pes (USA)
- Distribution
- Please see attached consignee list
- Recall date
- March 30, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)