Baxter Healthcare Corporation: Medical Device Recall in 2020 - (Recall #: Z-0713-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 23, 2020

Date Posted: December 30, 2020

Recall Number: Z-0713-2021

Event ID: 86758

Reason for Recall:

There is a potential software error during programming.

Status: Ongoing

Product Quantity: 293,926 devices

Code Information:

Product Code 35700BAX, GTIN 00085412091587

Distribution Pattern:

Worldwide distribution - US Nationwide distribution and the countries of Canada, Barbados, Jamaica, Bermuda, Guyana, Bahamas, and Trinidad and Tobago.

Voluntary or Mandated:

Voluntary: Firm initiated