BEUDAMED
    FDA Recall Open, Classified

    Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000

    Recall: Z-1420-2022 · Initiated June 3, 2022

    Recall

    Recall Number
    Z-1420-2022
    Event Number
    90488
    Firm
    Ambu Inc.
    FEI Number
    1121788
    Product Code
    CBI
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 3, 2022
    Address
    6230 Old Dobbin Ln, Ste 250, Columbia, MD, 21045-5955

    Description

    Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000

    Reason

    Firm has received complaints on the device concerning leak/rupture of either the bronchial or tracheal cuff. Leakage during procedure could lead to loss of secure airway and will require re-intubation of patient.

    Action

    On June 3, 2022, the firm notified customers of the recall through email. Customers were instructed to discard their affected product and report the amount back to the firm. The firm will provide replacement product or credit to affected customers.

    Distribution

    Domestic distribution nationwide. Foreign distribution to Austria, Belgium, Cyprus, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norge, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, UK Canada, Australia, New Zealand, Israel .

    Quantity

    12,921