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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

Baxter Spectrum IQ Infusion Pumps Recalled for Door Closing Malfunction

Agency Publication Date: November 8, 2024
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Summary

Baxter Healthcare Corporation is recalling 8 units of the Baxter Spectrum IQ Infusion System with Dose IQ Safety Software (Product Code 3570009). The recall was issued because the pump door may fail to close fully, which can prevent the device from functioning correctly. No incidents or injuries have been reported to date regarding this malfunction.

Risk

If the infusion pump door does not close completely, the device may fail to deliver necessary medications or fluids. This could result in a delay or interruption of critical therapy, which may lead to serious health complications for patients depending on continuous infusion.

What You Should Do

  1. This recall affects the Baxter Spectrum IQ Infusion System with Dose IQ Safety Software (Product Code 3570009). Only specific serial numbers are included in this recall.
  2. Identify if your device is affected by checking for these serial numbers: 3796578, 3797382, 3797464, 3797578, 3797728, 3797733, 3798019, and 3798200.
  3. Stop using the recalled device. Contact Baxter Healthcare Corporation or your distributor to arrange return, replacement, or correction.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions.

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: Baxter Spectrum IQ Infusion System with Dose IQ Safety Software
Model / REF:
3570009
Serial Numbers:
3796578
3797382
3797464
3797578
3797728
3797733
3798019
3798200
UDI:
00085412610900
GTIN:
00085412610900

Recall #: Z-0348-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95505
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: Baxter Healthcare Corporation
Manufactured In: United States
Units Affected: 8 units
Distributed To: Georgia, Idaho

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.