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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

Baxter Healthcare Corporation: There is a potential software error during programming.

Agency Publication Date: December 23, 2020
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Affected Products

Product: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.

Product Code 35700ABB, GTIN 00085412091570

Lot Numbers:
35700ABB
Product: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.

Product Code 35700BAX, GTIN 00085412091587

Lot Numbers:
35700BAX
Product: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administration of fluids.

Product Code 35700BAX2, GTIN 00085412498683

Lot Numbers:
35700BAX2
Product: Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used for the controlled administration of fluids.

Product Code 3570009, GTIN 00085412610900

Lot Numbers:
3570009

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86758
Status: Active
Manufacturer: Baxter Healthcare Corporation
Manufactured In: United States
Units Affected: 4 products (9,353 devices; 293,926 devices; 140,006 devices; 112,463 devices)

Were You Affected by This Recall?

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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 · 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.