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Recall Observatory FDA recall evidence

Device product

Spectrum IQ Infusion Pump, Product Code 3570009

Z-2415-2025

July 14, 2025

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 97335
Status
Ongoing
Classification
Class II
Quantity
6 units
Official record key
device-enforcement:Z-2415-2025

Official wording

Reason: Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the device having insufficient or ineffective grease applied to the cam, which could lead to premature wear of the mechanism assembly, resulting in excessive therapy.

Code information: UDI-DI: 00085412610900; Serial Numbers: 3815255 3815261 3815265 3815266 3815267 3815271

Distribution pattern: US distribution to states of: AZ, FL

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the device having insufficient or ineffective grease applied to the cam, which could lead to premature wear of the mechanism assembly, resulting in excessive therapy.