FDAClass IIJanuary 8, 2025

Baxter SIGMA Spectrum Infusion Pump with Master Drug recall

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX

Why was Baxter SIGMA Spectrum Infusion Pump with Master Drug recalled?

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

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?

GTIN 00085412091570; Serial Number: 779515

Product
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX
Recalling firm
Baxter Healthcare Corporation
Quantity
1 units
Distribution
US Nationwide distribution in the states of AL, IN.
Recall date
January 8, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls