Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to Recalled by Baxter Healthcare Corp. Due to Baxter Healthcare Corporation issued an Urgent Device Correction...

Date: June 10, 2013
Company: Baxter Healthcare Corp.
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 Corp. directly.

Affected Products

SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.

Quantity: 273,835 units

Why Was This Recalled?

Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Drug Library due to reports of upstream occlusion alarms and air-in-line alarms occurring during infusions.

Where Was This Sold?

Worldwide Distribution-USA including Puerto Rico and Canada.

About Baxter Healthcare Corp.

Baxter Healthcare Corp. has 126 total recalls tracked by RecallDetector.

Related Recalls

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