Recall Z-0702-2025— Augustine Temperature Management, LLC

Name: FDA recall Z-0702-2025
Creator: U.S. Food and Drug Administration
Published: 2024-12-04

Class II · Ongoing

Class II FDA medical device recall by Augustine Temperature Management, LLC, initiated 2024-12-04. It names 2 FDA 510(k) clearances: K220941, K201779. Product: Hillrom Temperature Management Controller, MP, Model # 2083516; 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"..

Recalling firm: Augustine Temperature Management, LLC
Classification: Class II
Status: Ongoing
Initiated: 2024-12-04
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

Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.

Reason for recall

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".

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