Baxter Healthcare Corporation: Medical Device Recall in 2023 - (Recall #: Z-2103-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

SIGMA Spectrum Infusion Pump, Product Code 35700BAX2

Product Classification:

Class I

Date Initiated: June 15, 2023

Date Posted: July 19, 2023

Recall Number: Z-2103-2023

Event ID: 92562

Reason for Recall:

A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported false upstream occlusion alarms following upgrades to software versions v8.01.01 and v9.02.01.

Status: Ongoing

Product Quantity: 3306 units

Code Information:

GTIN 00085412498683, Software version v8.01.01, Serial Numbers

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated