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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: Spectrum IQ Infusion Pump Recalled for Improper Testing

Agency Publication Date: May 3, 2024
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Summary

Baxter Healthcare Corporation is recalling one Baxter Spectrum IQ Infusion Pump (Product Code 3570009) because it was not properly tested before being released from a service center. This single affected pump, serial number 3540772, was distributed in Massachusetts. Because the required testing was not correctly performed, there is no assurance the device will function as intended during medical procedures. You should contact your healthcare provider or Baxter Healthcare Corporation to discuss the status of this specific device.

Risk

Improper testing prior to release means the device's mechanical or software functions may not meet safety standards, potentially leading to infusion errors or device failure during patient care. While no injuries have been reported for this specific unit, a malfunctioning infusion pump can result in the over-infusion or under-infusion of critical medications.

What You Should Do

  1. Identify if you have the affected device by checking the label for Baxter Spectrum IQ Infusion Pump, Product Code 3570009, with UDI/DI 00085412610900 and Serial Number 3540772.
  2. If you are a healthcare provider in Massachusetts using this specific serial number, contact Baxter Healthcare Corporation at 1 Baxter Pkwy, Deerfield, Illinois, 60015-4625 to arrange for proper testing or device evaluation.
  3. Patients who believe this device is being used for their care should contact their healthcare provider immediately for further instructions and to ensure their treatment remains uninterrupted.
  4. For additional information or questions regarding this recall, contact the FDA at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action

Contact manufacturer for evaluation

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

Affected Products

Product: Baxter Spectrum IQ Infusion Pump
Model / REF:
Product Code 3570009
UPC Codes:
00085412610900
Lot Numbers:
Serial Number 3540772

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94446
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: Service Center
Manufactured In: United States
Units Affected: 1 pump
Distributed To: Massachusetts

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.