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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

Fresenius Medical Care Holdings, Inc.: AquaA 900H Water Purification Systems Recalled for Pressure Errors

Agency Publication Date: June 13, 2024
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Summary

Fresenius Medical Care is recalling four US AquaA 900H-Typ USA-3 x 208v water purification systems intended for hemodialysis treatment. The systems can experience concentrate flow that exceeds safe pressure limits, triggering an error message (F 02 01 04) that automatically shuts down the water supply. This defect stops the essential flow of purified water required to perform dialysis, potentially interrupting patient care. The recall affects four specific units distributed in Alabama, Indiana, Alaska, and Wisconsin, and owners should contact the manufacturer or their healthcare provider for next steps.

Risk

High concentrate pressure levels trigger a system-wide safety shutdown that stops the dialysis water supply. This sudden interruption can prevent the start of treatment or disrupt an ongoing dialysis session, which is critical for patients with kidney failure.

What You Should Do

  1. Identify your device by checking the manufacturer label for the product name 'US AquaA 900H-Typ USA-3 x 208v' and Fresenius Part Number 24-090A-1 or Vivonic Part Number G02020110.
  2. Check the serial number on the side or back of the unit to see if it matches any of the four affected codes: 2AAV0003, 2AAV0029, 2AAV0037, or 3AAV0087.
  3. Verify the UDI-DI 04251285200357 printed on the device documentation or packaging.
  4. If your serial number matches, be alert for the error message 'F 02 01 04' (concentrate pressure alarm limit exceeded), which indicates the system has stopped providing water.
  5. Contact Fresenius Medical Care at 1-888-463-6332 or your healthcare provider immediately to discuss instructions for device service or replacement.
  6. Report any device malfunctions or treatment interruptions to the FDA's MedWatch program at 1-800-332-1088 or via their website at www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and device monitoring

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

Affected Products

Product: US AquaA 900H-Typ USA-3 x 208v Hemodialysis Water Purification System
Model / REF:
G02020110
24-090A-1
UPC Codes:
04251285200357
Lot Numbers:
2AAV0003
2AAV0029
2AAV0037
3AAV0087

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94676
Status: Active
Manufacturer: Fresenius Medical Care Holdings, Inc.
Sold By: Fresenius Medical Care; Authorized medical device distributors
Manufactured In: United States
Units Affected: 4 units
Distributed To: Alabama, Indiana, Alaska, Wisconsin

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.