BEUDAMED
    FDA Recall Open, Classified

    NIM TRIVANTAGE EMG Endotracheal Tube

    Recall: Z-0743-2022 · Initiated December 22, 2021

    Recall

    Recall Number
    Z-0743-2022
    Event Number
    89280
    Firm
    Medtronic Xomed, Inc.
    FEI Number
    1045254
    Product Code
    ETN
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    December 22, 2021
    Address
    6743 Southpoint Dr N, Jacksonville, FL, 32216-6218

    Description

    NIM TRIVANTAGE EMG Endotracheal Tube

    Reason

    There is potential for multiple issues due to a manufacturing nonconformity.

    Action

    Medtronic will distribute a removal notice to impacted U.S. consignees, on 22-Dec-2021. A second attempt to notify US consignees is scheduled for the week of 02-Feb-2022. A third attempt to notify US consignees is scheduled for the week of 16-Mar-2022. Consignees are asked to take the following actions immediately: 1) Do NOT use any impacted product. Remove and quarantine all unused impacted product(s) in your inventory. 2) Return the impacted product(s) to Medtronic. Your Medtronic representative can assist in facilitating the return of the product as necessary. If an alternative product is needed, your Medtronic representative can assist you with identifying a suitable replacement product. 3) Complete the attached Customer Confirmation Form, and fax it to Medtronic at 800-897-3899 or 651-367-0814 to the attention of the FCA Execution Team or email it to [email protected] Consignees are asked to share the communication within their organization and with other organizations where impacted devices have been transferred, and any other associated organizations that may be impacted by this action.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Faroe Islands, Finland, France, French Guinea, Germany, Greece, Guadeloupe, Guam, Guatemala, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Korea (Republic of), Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Mauritius, Mayotte, Mexico, Morocco, Namibia, Netherlands, New Caledonia, New Zealand, North Macedonia, Norway, Panama, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam.

    Quantity

    301,926 devices