Class II recallOngoing

Baxter SIGMA Spectrum Infusion System recall — FDA event 95848

FDA · FDA event 95848 · Posted Dec 27, 2024

Published Dec 27, 2024Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Devices were identified as released after repair without full testing being performed, which includes flow testing.

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

Customers were contacted via telephone beginning 11/19/24.
Baxter Healthcare is calling to notify you of a potential issue with the Spectrum infusion pump. One of your devices has been identified as released after repair without full testing being performed, which includes flow testing. Baxter is requesting the return of the impacted infusion pump to perform all tests required and confirm that the infusion pump performs as expected.
As part of this process, we need to make you aware of the potential hazard associated with flow related issues. Flow issues may cause excessive therapy, free-flow condition, insufficient therapy or interruption of therapy. These may lead to serious adverse health consequences, including permanent injury and death.
Send signed form to Global CORP Service Quality Field Actions Global_CORP_Service_Quality_Field_Actions@baxter.com

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This record references Baxter SIGMA Spectrum Infusion System by Baxter Healthcare Corporation.

Products affected by FDA event 95848
Model	Description	Lot / serial range	Manufactured	Status
Z-0776-2025	Z-0776-2025	GTIN 00085412498683; Serial Number: 2153638	Not provided in the normalized record	Ongoing
Z-0775-2025	Z-0775-2025	GTIN 00085412091570; Serial Number: 779515	Not provided in the normalized record	Ongoing

Distribution: US Nationwide distribution in the states of AL, IN.
Units affected: See official FDA record
Category: Infusion pumps

Timeline

Nov 19, 2024
Recall initiated
Date recorded by the FDA.
Dec 27, 2024
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 95848
Published: Dec 27, 2024
Source checked: 2026-10-08 16:03:16 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

How MedWatcher checks these sources

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Baxter SIGMA Spectrum Infusion System recall — FDA event 95848

FDA · FDA event 95848 · Posted Dec 27, 2024

Published Dec 27, 2024Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

Affected products and models

Products affected by FDA event 95848
Model	Description	Lot / serial range	Manufactured	Status
Z-0776-2025	Z-0776-2025	GTIN 00085412498683; Serial Number: 2153638	Not provided in the normalized record	Ongoing
Z-0775-2025	Z-0775-2025	GTIN 00085412091570; Serial Number: 779515	Not provided in the normalized record	Ongoing

Distribution

US Nationwide distribution in the states of AL, IN.

Units affected

See official FDA record

Baxter SIGMA Spectrum Infusion System recall — FDA event 98167

FDA · FDA event 98167Posted Jan 16, 2026Baxter SIGMA Spectrum Infusion System

Class I recallOngoing

Baxter SIGMA Spectrum Infusion Pump V6 and V8 recall — FDA event 97072

Certain Spectrum infusion pumps may have an incorrect version of software.

FDA · FDA event 97072Posted Jul 17, 2025Baxter SIGMA Spectrum Infusion System

Class II recallOngoing

Baxter SIGMA Spectrum Infusion System recall — FDA event 94988

FDA · FDA event 94988Posted Aug 16, 2024Baxter SIGMA Spectrum Infusion System

Baxter SIGMA Spectrum Infusion System recall — FDA event 95848

Follow Baxter SIGMA Spectrum Infusion System

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Baxter SIGMA Spectrum Infusion System recall — FDA event 95848

Follow Baxter SIGMA Spectrum Infusion System

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline