BEUDAMED
    FDA Enforcement Class II Terminated

    #1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED

    Recall: Z-1288-2022 · Reported July 6, 2022

    Enforcement

    Recall Number
    Z-1288-2022
    Event ID
    90273
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 6, 2022
    Initiation Date
    May 17, 2022
    Classification Date
    June 24, 2022
    Termination Date
    May 4, 2026
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    Description

    #1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED

    Reason

    Packaging error.

    Code Info

    Product Codes: 69061 (UDI/DI:732094141382), 69696 (UDI/DI: 732094141078), 69696-LED (UDI/DI: 732094230697); Lot code: 21-056

    Distribution

    Worldwide distribution - US Nationwide and the countries of Japan, Canada, Australia, New Zealand, Spain, Brunei Darussalam, Brazil, India, Colombia, Czechia, Egypt, Turkey, South Africa, Argentina, Mexico, Congo, United Arab Emirates, El Salvador, South Korea, Germany, Cameroon, Guyana, Austria, Bahamas, Bahrain, Bangladesh, Bolivia, Chile, Costa Rica, Dominican Republic, Finland, Guatemala, Honduras, Indonesia, Italy, Kuwait, Libya, Maldives, Namibia, Netherlands, Pakistan, Peru, Philippines, Poland, Saudi Arabia, Trinidad and Tobago, Ukraine, Vietnam.

    Quantity

    99 units