🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: February 10, 2016 Ambu Infusion Pumps

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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.

Product Codes/Lot Numbers:

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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1236-2016

Related Recalls

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Ambu

Class I - Dangerous

Potential for the manometer port being blocked rendering the manometer non-functional.

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