Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) Recalled by Baxter Healthcare Corporation Due to Baxter is updating the device IFU for safety...

Date: June 30, 2020
Company: Baxter Healthcare Corporation
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Baxter Healthcare Corporation directly.

Affected Products

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)

Quantity: 310,969 units

Why Was This Recalled?

Baxter is updating the device IFU for safety communication regarding cleaning practices.

Where Was This Sold?

Distribution throughout the United States, St. Thomas USVI, and Puerto Rico. Foreign distribution including Canada, Caribbean (Barbados, Trinidad and Tobago, Jamaica, Bahamas, Bermuda, and Guyana)

About Baxter Healthcare Corporation

Baxter Healthcare Corporation has 401 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report