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Open, Classified

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

FDA Recall Z-1368-2026 · Posted 2026-02-13

Recalling FirmBaxter Healthcare Corporation
Recall StatusOpen, Classified
Product CodeFRN
Date Initiated2026-01-13
Product Quantity5

Reason for Recall

Pumps were released without full testing being performed, including occlusion alarm testing.

Firm Action

Firm notified the single customer on 1/13/26 via phone call. Customer was asked to work with on-site service technician to coordinate return of affected product.

Root Cause

Employee error

Distribution Pattern

States: Ohio Countries: United States

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare Corporation · 2025-07-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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