Baxter Healthcare Corporation: Medical Device Recall in 2022 - (Recall #: Z-0530-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.

Product Classification:

Class I

Date Initiated: December 29, 2021

Date Posted: February 9, 2022

Recall Number: Z-0530-2022

Event ID: 89017

Reason for Recall:

There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms when using Spectrum V8 and Spectrum IQ infusion pumps.

Status: Ongoing

Product Quantity: 146,502 units

Code Information:

All serial numbers, GTIN 00085412498683.

Distribution Pattern:

Worldwide Distribution. US nationwide Puerto Rico and St. Thomas. There was government/military distribution. Countries of Canada, Bahamas, Barbados, Bermuda, Guyana, Jamaica, and Trinidad and Tobago.

Voluntary or Mandated:

Voluntary: Firm initiated