FDAHealthJune 20, 2025

Baxter Healthcare Corporation — Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX

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

Is this relevant to me?

Geography: US, CA, FL, IL, KS, MI, MS, NY, OH, OK, VA
Source agency: FDA
Category: Health
Published: June 20, 2025

US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.

What's affected?

Product: Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
Brand: Baxter Healthcare Corporation
Lot code: UDI-DI: 00085412091570; Serial Numbers: 765100 , 772744 , 789742 , 841197 , 867753 , 920606 , 1024015 770164 788724 , 793079 , 842498 , 918342 , 962810 , 1027523

Additional details

UDI-DI: 00085412091570; Serial Numbers: 765100 , 772744 , 789742 , 841197 , 867753 , 920606 , 1024015 770164 788724 , 793079 , 842498 , 918342 , 962810 , 1027523

What should I do?

Recommended action

Class I recall. Voluntary: Firm initiated Quantity affected: 14 units.

View original FDA notice →

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