BEUDAMED
    FDA Recall Open, Classified

    Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Mattresses.

    Recall: Z-1172-2025 · Initiated February 15, 2024

    Recall

    Recall Number
    Z-1172-2025
    Event Number
    95914
    Firm
    Augustine Temperature Management, LLC
    FEI Number
    3005857264
    Product Code
    DWJ
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    February 15, 2024
    Posted
    February 14, 2025
    Address
    15305 Minnetonka Blvd, Minnetonka, MN, 55345-1512

    Description

    Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Mattresses.

    Reason

    Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .

    Action

    Augustine Temperature Management contacted their consignees by visit beginning on 02/15/2024 to replace the affected cables. The firm collected email confirmation that the original cables had either been returned or destroyed. If you have any questions, contact the Product Manager at 952-465-3526 or email:

    Distribution

    US distribution to states of: AL, TX, NV

    Quantity

    7 unit