Z-0700-2025 Class II Ongoing

Recalled by Augustine Temperature Management, LLC — Minnetonka, MN

Recall Details

Product Type
Devices
Report Date
December 25, 2024
Initiation Date
December 4, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
135 units

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

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".

Distribution Pattern

US and Canada

Code Information

1) UDI-DI 00850011479018, Serial Numbers: 20080004-23060141; 2) UDI-DI 00850011479285, Serial Numbers: 20080004-23060141