BEUDAMED
    FDA Enforcement Class II Completed

    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.

    Recall: Z-0839-2025 · Reported January 22, 2025

    Enforcement

    Recall Number
    Z-0839-2025
    Event ID
    95913
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Augustine Temperature Management, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    January 22, 2025
    Initiation Date
    March 14, 2022
    Classification Date
    January 10, 2025
    Address
    15305 Minnetonka Blvd, Minnetonka, MN, 55345-1512, United States

    Description

    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.

    Reason

    HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".

    Code Info

    1) UDI-DI 00850011479018, Serial Numbers: 23060144, 22030085, 22030087, 22030088, 23060138, 23060139, 22030075, 22030076, 22030077, 22030079, 22030080, 22030081, 22030082, 22030083, 22030084, 23060141; 2) UDI-DI 00850011479285, Serial Numbers: 20080002

    Distribution

    Worldwide

    Quantity

    17 units