Recall Z-0839-2025— Augustine Temperature Management, LLC

Name: FDA recall Z-0839-2025
Creator: U.S. Food and Drug Administration
Published: 2022-03-14

Class II · Completed

Class II FDA medical device recall by Augustine Temperature Management, LLC, initiated 2022-03-14. It names 2 FDA 510(k) clearances: K220941, K201779. Product: 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"..

Recalling firm: Augustine Temperature Management, LLC
Classification: Class II
Status: Completed
Initiated: 2022-03-14
Firm location: Minnetonka, MN, United States

510(k) clearances named in this recall

2 on FDA's record

K220941 — HotDog Temperature Management SystemAugustine Temperature Management·cleared 2022-09-23
K201779 — HotDog Temperature Management ControllerAugustine Temperature Management·cleared 2020-09-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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 for recall

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".

Data sourced from openFDA. This site is unofficial and independent of the FDA.