FDAClass IJuly 23, 2025

Baxter SIGMA Spectrum Infusion Pump V6 recall: Software Issue

Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX

Why was Baxter SIGMA Spectrum Infusion Pump V6 recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
Recalling firm
Baxter Healthcare Corporation
Quantity
14 units
Distribution
US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.
Recall date
July 23, 2025
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls