BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1288-2022 · Initiated May 17, 2022

    Recall

    Recall Number
    Z-1288-2022
    Event Number
    90273
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    CCW
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 17, 2022
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

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

    Reason

    Packaging error.

    Action

    The firm issued a recall notification on 05/17/2022 via UPS. The letter instructs the consignee to check their inventory, contact the firm to arrange a return and replacement of mislabeled package, verify contents of all sterile packs are labeled correctly, and complete a response form. Distributors are to share the notification with end users.

    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