BEUDAMED
    FDA Enforcement Class II Ongoing

    Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia

    Recall: Z-1197-2025 · Reported February 26, 2025

    Enforcement

    Recall Number
    Z-1197-2025
    Event ID
    96155
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Augustine Temperature Management, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    February 26, 2025
    Initiation Date
    December 16, 2024
    Classification Date
    February 20, 2025
    Address
    15305 Minnetonka Blvd, N/A, Minnetonka, MN, 55345-1512, United States

    Description

    Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia

    Reason

    There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU.

    Code Info

    UDI-DI UDI-DI 00855913001817, Serial Numbers: 1304292, 1304293, 1304296, 1304297

    Distribution

    US Nationwide distribution in the states of TX, AL, NV; AU, NZ.

    Quantity

    4 units