BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1197-2025 · Initiated December 16, 2024

    Recall

    Recall Number
    Z-1197-2025
    Event Number
    96155
    Firm
    Augustine Temperature Management, LLC
    FEI Number
    3005857264
    Product Code
    DWJ
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    December 16, 2024
    Posted
    February 20, 2025
    Address
    15305 Minnetonka Blvd, Minnetonka, MN, 55345-1512

    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.

    Action

    Augustine Temperature Management began notifying its consignees on 12/16/2024 via email and visit to exchange the affected product.

    Distribution

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

    Quantity

    4 units