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Recall Observatory FDA recall evidence

Device product

Spectrum IQ Infusion pump, Product Code 357009

Z-1810-2024

April 09, 2024

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 94451
Status
Ongoing
Classification
Class II
Quantity
9 units
Official record key
device-enforcement:Z-1810-2024

Official wording

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

Code information: UDI/DI 00085412610900, Serial Numbers: 3770692, 3770755, 3770781, 3770816, 3770932, 3771122, 3771364, 3771374, 3771419

Distribution pattern: US Nationwide distribution in the states of Ohio, Wisconsin.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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