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Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, ...

FDA Recall #Z-0700-2025 — Class II — December 4, 2024

Recall #Z-0700-2025 Date: December 4, 2024 Classification: Class II Status: Ongoing

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".

Recalling Firm

Augustine Temperature Management, LLC — Minnetonka, MN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

135 units

Distribution

US and Canada

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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