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Recall Observatory FDA recall evidence

Device product

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

Z-0348-2025

October 02, 2024

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 95505
Status
Ongoing
Classification
Class II
Quantity
8 units
Official record key
device-enforcement:Z-0348-2025

Official wording

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

Code information: 00085412610900, Serial Numbers: 3796578, 3797382, 3797464, 3797578, 3797728, 3797733, 3798019, 3798200

Distribution pattern: GA, ID

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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