BEUDAMED
    FDA Enforcement Class II Ongoing

    Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01.

    Recall: Z-1413-2022 · Reported July 27, 2022

    Enforcement

    Recall Number
    Z-1413-2022
    Event ID
    90511
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 27, 2022
    Initiation Date
    June 24, 2022
    Classification Date
    July 20, 2022
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01.

    Reason

    The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in an increased patient risk of pressure ulcer development.

    Code Info

    UDI 00887761977860, Serial numbers: W214BP3955, W214BP3956, W243BP4436, W243BP4438, W243BP4445, W243BP4446, W243BP4447, and W243BP4448.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, GA, IA, IN, KY, LA, MD, MI, MN, MO, NC, NJ, NM, NM, NY, OH, OK, RI, SD, TN, TX, VT, and WI. There was government distribution but no military distribution. The country of Canada.

    Quantity

    8 mattresses