Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses
Summary
The FDA issued a Class II for Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunct by Augustine Temperature Management, LLC. Reason: Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 per.
Details
Source
Device Recall
External ID
Z-0702-2025
Action Date
2024-12-25
Status
Ongoing
Category
device
Product Description
Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.
Lot/Code Info: UDI-DI 00850011479582, Serial Numbers: 22120000-24030030
Quantity Affected: 116 units
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
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-04
Company
Minnetonka, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 157 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Augustine Temperature Management, LLC has 15 FDA actions in our database, including 13 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Augustine Temperature Management, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Augustine Temperature Management, LLC have FDA actions?
Augustine Temperature Management, LLC has 15 FDA actions in our database, including 13 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0702-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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