Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library Recalled by Baxter Healthcare Corp. Due to A correction was issued for the SIGMA Spectrum...
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
sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, Product Code 35700BAX and 35700BAXR, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Sigma, LLC Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in the back of the infusion pump. The speaker is intended to generate audible tones during each keystroke, and during alarm conditions. However, some speakers have a variation in their internal wiring that increases the potential for the speaker to fail prematurely. Spectrum Infusion Pumps with non-functional speakers will continue to display visual alarm indications, and will otherwise continue to operate as intended.
Quantity: 5,976 units (US: 5972, Canada: 4)
Why Was This Recalled?
A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to replace speakers installed in pumps or included in spare part rear case assemblies that have an increased potential to fail prematurely.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Baxter Healthcare Corp.
Baxter Healthcare Corp. has 126 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report