Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Ver...
FDA Recall #Z-1368-2026 — Class II — January 13, 2026
Product Description
Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A
Reason for Recall
Pumps were released without full testing being performed, including occlusion alarm testing.
Recalling Firm
Baxter Healthcare Corporation — Deerfield, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
5
Distribution
States: Ohio Countries: United States
Code Information
Lot Code: GTIN 00085412610900, Serial Numbers 3815663, 3823468, 3824743, 3825234, and 3825599
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated