Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Master Drug Library Software version 8.0 Recalled by Baxter Healthcare Corp Due to Loading/Bolus default dose settings in the Master Drug...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Baxter Healthcare Corp directly.
Affected Products
Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2 The SIGMA Spectrum Infusion Pump with Master Drug Library (MDL) is intended to be used for the controlled administration of fluids.
Quantity: 58 MDLs
Why Was This Recalled?
Loading/Bolus default dose settings in the Master Drug Library and the values shown on the pump during programming may differ. MDL drug dose time in seconds will round to the nearest integer in minutes on the pump dose setup screen (20 sec may show as 1 min on the pump display). The pump will administer drugs as configured. The discrepancy may cause therapy delay or unintended rate of delivery.
Where Was This Sold?
This product was distributed to 20 states: CA, CT, FL, IL, IN, IA, LA, MD, MA, MI, MN, MO, NE, NH, NY, NC, SD, TX, UT, WV
About Baxter Healthcare Corp
Baxter Healthcare Corp has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report