BEUDAMED
    FDA Enforcement Class II 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 · Reported March 30, 2016

    Enforcement

    Recall Number
    Z-1236-2016
    Event ID
    73366
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ambu Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 30, 2016
    Initiation Date
    February 10, 2016
    Classification Date
    March 24, 2016
    Termination Date
    June 22, 2016
    Address
    6230 Old Dobbin Ln Ste 250, N/A, Columbia, MD, 21045-5955, United States

    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.

    Code Info

    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.

    Distribution

    Please see attached consignee list

    Quantity

    Total Numbers of unit distributed: 45990 pes (USA)