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Open, Classified

Spectrum IQ Infusion pump, Product Code 357009

FDA Recall Z-1810-2024 · Posted 2024-05-13

Recalling FirmBaxter Healthcare Corporation
Recall StatusOpen, Classified
Product CodeFRN
Date Initiated2024-04-09
Product Quantity9 units

Reason for Recall

There is a potential for cracks on the mount of the front panel of the device.

Firm Action

Baxter notified its consignees of the issue and requested an on-site inspection of the affected units on 04/09/2024 via telephone.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the states of Ohio, Wisconsin.

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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