Medical device recalls Moderate risk

Augustine Temperature Management, LLC recalls Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC77,…

Recall date
December 4, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0701-2025
FDA classification
Class II
Brand / firm
Augustine Temperature Management, LLC
Sold / distributed
US and Canada

Why it was recalled

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".

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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