Critical RiskFDA Device

Baxter Healthcare Corporation: There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms when using Spectrum V8 and Spectrum IQ infusion pumps.

Agency Publication Date: January 29, 2022

Affected Products

Product: Baxter Spectrum IQ Infusion Pumps, Product code 3570009.

All serial numbers, GTIN 00085412610900.

Product: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.

All serial numbers, GTIN 00085412498683.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89017

Status: Active

Manufacturer: Baxter Healthcare Corporation

Manufactured In: United States

Units Affected: 2 products (241,304 units; 146,502 units)

Agency Last Updated: March 14, 2022

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 · FDA Press Release · 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.