BEUDAMED
    FDA Enforcement Class II Ongoing

    Isolibrium Support Surface - support surface assists in the prevention and treatment of all pressure injury stages (including stages 1, 2, 3, 4, Unstageable and Deep Tissue Pressure Injury, Model Number: 2972, Part # 2972000000

    Recall: Z-2215-2021 · Reported August 18, 2021

    Enforcement

    Recall Number
    Z-2215-2021
    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

    Isolibrium Support Surface - support surface assists in the prevention and treatment of all pressure injury stages (including stages 1, 2, 3, 4, Unstageable and Deep Tissue Pressure Injury, Model Number: 2972, Part # 2972000000

    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: 219009000417 UDI: 07613327278453

    Distribution

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

    Quantity

    1 unit