Baxter SIGMA Spectrum Infusion Pump V8 recall: Software Issue
Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
Why was Baxter SIGMA Spectrum Infusion Pump V8 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: 00085412498683; Serial Numbers: 2006307 , 2052091 , 2093765 , 2095360 , 2104302 , 2119236 , 2141815 , 2025925 , 2067699 , 2094483 , 2095541 , 2105238 , 2119436 , 2143406 , 2034297 , 2074097 , 2094580 , 2096351 , 2105769 , 2135482 , 2143684 , 2051591 , 2090658 , 2095202 , 2096856 , 2118940 , 2137976 , 2156201
- Product
- Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 28 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)