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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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Critical RiskFDA Device
Medical Devices

Fresenius Kabi Ivenix Infusion System Recalled for Potential Valve Failure

Agency Publication Date: January 8, 2025
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Summary

Fresenius Kabi USA, LLC has recalled 1,520 units of the Ivenix Infusion System (IIS) Large Volume Pump (Model LVP-0004). The recall is due to a potential failure of a pneumatic valve within the pump that could cause it to stop delivering medication or fluids during an active infusion, or prevent the pump from starting at all. No injuries or incidents have been reported, but the manufacturer is initiating this correction to address the defect.

Risk

A valve failure can lead to an unexpected stop in the delivery of critical fluids or medications to a patient. This interruption in treatment could result in serious health complications, especially for patients who are dependent on continuous medication delivery.

What You Should Do

  1. The recalled products are Ivenix Infusion System (IIS) Large Volume Pumps (Model LVP-0004) with Unique Device Identifier (UDI) 00811505030320.
  2. Check the device label on your pump for the serial number. There are 1,520 specific serial numbers affected. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately.
  4. Contact Fresenius Kabi USA, LLC or your medical equipment distributor to arrange for a return, replacement, or correction of the affected unit.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional assistance.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Ivenix Infusion System (IIS), Large Volume Pump
Model / REF:
LVP-0004
Serial Numbers (1520):
9233532106
9233421830
9233421828
9233532158
9233522076
9233522041
9233421833
9233421829
9233421808
9233421654
9233421626
9233421621
9233321340
2215401517
2215401545
9233421789
9233421809
9233532167
9233532100
9233522070
9233421825
9233421824
9233421794
9233421783
9233421781
9233421771
9233421768
9233421756
9233421736
9233421713
9233421702
9233421617
9233421611
9233391513
9233391491
9233532098
9233421822
9233421797
9233421678
9233421666
9233421601
9233532114
9233421792
9233421766
9233421687
2215401372
9233522040
9233522037
9233421764
9233421752
UDI:
00811505030320

Recall Number: Z-0763-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95891
Status: Active
Manufacturer: Fresenius Kabi USA, LLC
Sold By: Authorized Medical Distributors
Manufactured In: United States
Units Affected: 1,520 units
Distributed To: Idaho, Minnesota, Nevada, Texas, Virginia, 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.