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

FDA Recall #Z-0702-2025 — Class II — December 4, 2024

Recall #Z-0702-2025 Date: December 4, 2024 Classification: Class II Status: Ongoing

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".

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

116 units

Distribution

US and Canada

Code Information

UDI-DI 00850011479582, Serial Numbers: 22120000-24030030

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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