Reported Mar 30, 2016 · Terminated
Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternative to a face mask for achieving and…
Ambu Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ambu Inc. · 6230 Old Dobbin Ln Ste 250 · Columbia, MD · 21045-5955
Is this the product you have?
- 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.
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Product as published — lot number 1808911except 408400000lot number 1779966,1782239, 1795914 Size #4 All lots from 1632799 through 408500000lot number 1790075. Size #5 All lots from 1632802 through — lot number 1810863. - Amount recalled
- Total Numbers of unit distributed: 45990 pes (USA)
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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