FDA recall Z-0702-2025

Augustine Temperature Management, LLC · Class II · device

Product

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".

Distribution

US and Canada

Key facts

Status
Ongoing
Initiation date
2024-12-04
Report date
2024-12-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Minnetonka, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0702-2025