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Recall Observatory FDA recall evidence

Device product

Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A

Z-1368-2026

January 13, 2026

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 98306
Status
Ongoing
Classification
Class II
Quantity
5
Official record key
device-enforcement:Z-1368-2026

Official wording

Reason: Pumps were released without full testing being performed, including occlusion alarm testing.

Code information: Lot Code: GTIN 00085412610900, Serial Numbers 3815663, 3823468, 3824743, 3825234, and 3825599

Distribution pattern: States: Ohio Countries: United States

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Pumps were released without full testing being performed, including occlusion alarm testing.