Baxter Healthcare Corporation: Medical Device Recall in 2020 - (Recall #: Z-0121-2021)

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 8)

Product Classification:

Class I

Date Initiated: June 30, 2020

Date Posted: October 28, 2020

Recall Number: Z-0121-2021

Event ID: 86062

Reason for Recall:

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

Status: Terminated

Product Quantity: 310,969 units

Code Information:

Product Code: 35700BAX, All Serial Numbers; GTIN 00085412091570

Distribution Pattern:

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)

Voluntary or Mandated:

Voluntary: Firm initiated