BEUDAMED
    FDA Enforcement Class II Ongoing

    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.

    Recall: Z-0701-2025 · Reported December 25, 2024

    Enforcement

    Recall Number
    Z-0701-2025
    Event ID
    95703
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Augustine Temperature Management, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 25, 2024
    Initiation Date
    December 4, 2024
    Classification Date
    December 18, 2024
    Address
    15305 Minnetonka Blvd, Minnetonka, MN, 55345-1512, United States

    Description

    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.

    Reason

    Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST".

    Code Info

    1) UDI-DI 00850011479025, Serial Numbers: 20080060-24060065; 2) UDI/DI 00850011479292, Serial Numbers: 20080060-24060065; 3) UDI-DI 00850011479308, Serial Numbers: 20080060-24060065

    Distribution

    US and Canada

    Quantity

    1776 units