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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/Home Healthcare

Baxter Healthcare Corporation: SIGMA Spectrum Infusion Pump Recalled for Improper Testing Prior to Release

Agency Publication Date: August 7, 2024
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Summary

Baxter Healthcare Corporation is recalling one unit of the Baxter SIGMA Spectrum Infusion Pump because it was released without properly performed testing. This specific device, identified by serial number 2158913, may not function as intended during medical procedures due to the lack of verified safety checks. The affected pump was distributed to a facility in Florida.

Risk

The failure to perform required testing prior to release means the device's accuracy and safety mechanisms have not been confirmed, which could lead to incorrect medication delivery or device failure during critical patient care. No injuries have been reported specifically for this unit, but improper infusion rates can cause serious health complications.

What You Should Do

  1. Locate the Baxter SIGMA Spectrum Infusion Pump and check the serial number on the back or side of the device.
  2. Verify if your device matches Serial Number 2158913 and Product Code 35700BAX2.
  3. If you identify this specific unit, stop using it immediately and remove it from patient care areas.
  4. Contact your healthcare provider or Baxter Healthcare Corporation directly at 1-888-463-6332 to discuss the return of the device and potential replacement or refund options.
  5. For additional questions, contact the FDA's consumer line at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer instruction

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

Affected Products

Product: Baxter SIGMA Spectrum Infusion Pump
Model / REF:
35700BAX2
Lot Numbers:
35700BAX2
Serial Number: 2158913

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94959
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: Direct distribution
Manufactured In: United States
Units Affected: 1 unit
Distributed To: Florida

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.