FDA recall Z-0839-2025

Augustine Temperature Management, LLC · Class II · device

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 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".

Distribution

Worldwide

Key facts

Status: Completed
Initiation date: 2022-03-14
Report date: 2025-01-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Minnetonka, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0839-2025