BEUDAMED
    FDA Enforcement Class II Ongoing

    GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX

    Recall: Z-2223-2021 · Reported August 18, 2021

    Enforcement

    Recall Number
    Z-2223-2021
    Event ID
    88199
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stryker Medical Division of Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    August 18, 2021
    Initiation Date
    May 12, 2021
    Classification Date
    August 6, 2021
    Address
    3800 E Centre Ave, N/A, Portage, MI, 49002-5826, United States

    Description

    GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX

    Reason

    Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

    Code Info

    Serial Numbers: R52495 R53376 R55047 R56034 M14805 M14885 M14886 M14931 M14936 M14938 M14939 M50074 M50425 M50951 M50956 M54387 R63407 R54523 R54610 R54696 R54698 R60775 R32649 R25384 R35631 R35734 R58735 M15330 R58474 UDI: 07613327169355 07613327169386

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.

    Quantity

    33 units