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Recall Observatory FDA recall evidence

Device product

Baxter Spectrum IQ Infusion Pump, Product Code 3570009

Z-1775-2024

March 20, 2024

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 94446
Status
Ongoing
Classification
Class II
Quantity
1 pump
Official record key
device-enforcement:Z-1775-2024

Official wording

Reason: One device was improperly performed testing prior to release from a Service Center.

Code information: UDI/DI 00085412610900, Serial Number 3540772

Distribution pattern: US Nationwide distribution in the state of Massachusetts.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    One device was improperly performed testing prior to release from a Service Center.