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Open, Classified

Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

FDA Recall Z-0348-2025 · Posted 2024-11-08

Recalling FirmBaxter Healthcare Corporation
Recall StatusOpen, Classified
Product CodeFRN
Date Initiated2024-10-02
Product Quantity8 units

Reason for Recall

The door on the Spectrum IQ Infusion pump may not be able to fully close.

Firm Action

Baxter Healthcare notified its consignees on 10/03 and 04/2024 via telephone. The call included information regarding the problem with the device, risk to health, and requested the affected units be removed from service pending inspection. On-site inspections to assess for impact and offer replacement, were scheduled.

Root Cause

Process control

Distribution Pattern

GA, ID

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K230041Spectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2023-03-31

Official Source

View FDA Recall →

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

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