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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

HotDog and Hillrom Temperature Controllers Recalled for Self-Test Error Update

Agency Publication Date: December 18, 2024
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Summary

Augustine Temperature Management, LLC is updating the instructions for use for 2,027 HotDog and Hillrom Temperature Management Controllers. The recall affects several models, including the HotDog WC71 and WC77 series and the Hillrom MP Model 2083516. The update is necessary to provide proper guidance on how to handle the "EA POST" error code that may appear during the device's power-on self-test. No incidents or injuries have been reported to date.

Risk

The "EA POST" error occurs during the device's initial safety check. Without updated instructions on how to address this error, medical staff may experience delays in warming patients during surgery or recovery, potentially leading to temperature management issues.

What You Should Do

  1. This recall involves Augustine Surgical HotDog Temperature Management Controllers (Models WC71, WC71R, WC77, WC77D, WC77R) and Hillrom Temperature Management Controllers (Model 2083516).
  2. Check your device's model number and serial number on the manufacturer label to see if your unit is affected. Affected serial numbers fall within the ranges 20080004-23060141, 20080060-24060065, or 22120000-24030030 depending on the specific model. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction of the instructions for use.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for more information regarding this device recall.

Your Remedy Options

๐Ÿ“‹Other Action

Correction of Instructions for Use

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port
Variants: Standard, Refurbished
Model / REF:
WC71
WC71R
Serial Numbers:
20080004-23060141
UDI:
00850011479018
00850011479285

Used in conjunction with Warming Blankets and Mattresses.

Product: Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport
Variants: Standard, Demo, Refurbished
Model / REF:
WC77
WC77D
WC77R
Serial Numbers:
20080060-24060065
UDI:
00850011479025
00850011479292
00850011479308

Used in conjunction with Warming Blankets and Mattresses.

Product: Hillrom Temperature Management Controller, MP
Model / REF:
2083516
Serial Numbers:
22120000-24030030
UDI:
00850011479582

Used in conjunction with Warming Blankets and Mattresses.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95703
Status: Active
Manufacturer: Augustine Temperature Management, LLC
Sold By: Augustine Surgical Inc.; Hillrom; Medical distributors
Manufactured In: United States
Units Affected: 3 products (135 units; 1776 units; 116 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.