Z-0776-2025Class II

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

Name: Z-0776-2025 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
Creator: Baxter Healthcare Corporation
Published: 2024-11-19
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2024-11-19 / Open, Classified / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2 on 2024-11-19. FDA classified it as Class II and gives the reason as "Devices were identified as released after repair without full testing being performed, which includes flow testing". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0776-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-19
Posted: 2024-12-27
Recalling firm: Baxter Healthcare Corporation
Product: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
Product code: FRN Pump, Infusion
Reason for recall: Devices were identified as released after repair without full testing being performed, which includes flow testing.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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 [email protected]
Quantity in commerce: 1 unit
Distribution: US Nationwide distribution in the states of AL, IN.
Product codes and lots: GTIN 00085412498683; Serial Number: 2153638

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0776-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0775-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-08	2024-12-27
Z-0776-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-08	2024-12-27

Product code FRN

K230022Class IIBaxter SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation / cleared 2023-03-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)