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Recall Observatory FDA recall evidence

Device product

Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2

Z-2530-2024

June 14, 2024

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 94959
Status
Ongoing
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-2530-2024

Official wording

Reason: Improperly performed testing prior to release

Code information: Product Code: 35700BAX2. Serial Number: 2158913.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Improperly performed testing prior to release