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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/Monitoring Devices

Baxter Healthcare Corporation: Braun Thermoscan PRO 6000 Recalled for Outdated Instructions for Use

Agency Publication Date: July 11, 2024
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Summary

Baxter Healthcare Corporation is recalling approximately 265,647 units of the Braun Thermoscan PRO 6000 Ear Thermometer. These medical devices may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU). Because the instructions provided do not match the current requirements for the device, users may not have access to the most accurate guidance for operating the thermometer or interpreting results. If you own this thermometer, please contact Baxter Healthcare or your healthcare provider for updated information and to ensure you have the correct usage guidelines.

Risk

The use of outdated instructions can lead to incorrect operation of the thermometer or misinterpretation of temperature readings, which could potentially result in delayed or inappropriate medical treatment.

What You Should Do

  1. Locate your thermometer and check for the model name 'Braun Thermoscan PRO 6000' and look for product codes 06000-200 or 06000-300.
  2. Check the device packaging or documentation for UDI numbers 00732094309003 or 00732094309027 to see if your unit is part of the 265,647 units affected.
  3. If you have the compact disc (CD) that came with the device, stop using the instructions provided on that disc immediately.
  4. Contact Baxter Healthcare Corporation at 1 Baxter Pkwy, Deerfield, Illinois, or your healthcare provider to obtain the most recent version of the Instructions for Use (IFU).
  5. For additional questions or to report issues, contact the FDA hotline at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

📋Other Action

Obtain current Instructions for Use (IFU)

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Braun Thermoscan PRO 6000 Ear Thermometer (Product Code 06000-200)
Model / REF:
06000-200
Lot Numbers:
06000-200
Product: Braun Thermoscan PRO 6000 Ear Thermometer (Product Code 06000-300)
Model / REF:
06000-300
Lot Numbers:
06000-300

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94825
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: medical distributors
Manufactured In: United States
Units Affected: 265,647 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 · 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.