Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Recalled by Sigma Due to Sigma is a safety alert for the Master...

Date: April 23, 2012
Company: Sigma
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 Sigma directly.

Affected Products

SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters.

Quantity: 2,048 CD's

Why Was This Recalled?

Sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with the SIGMA Spectrum Infusion Pump System because it may result in a facility drug library that does not represent common clinical practices.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Sigma

Sigma has 1 total recall tracked by RecallDetector.

Related Recalls

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