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Recall Observatory FDA recall evidence

Device product

SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug Library are intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.

Z-1484-2014

February 07, 2014

Class I

Product summary

Firm
Baxter Healthcare Corp.
Event
Event 67523
Status
Terminated
Classification
Class I
Quantity
277,096 units (revised)
Official record key
device-enforcement:Z-1484-2014

Official wording

Reason: Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library due to repeated System Error 322 occurrences.

Code information: Product Codes: 35700BAX, 35700ABB

Distribution pattern: Worldwide Distribution - USA Nationwide including PR and the country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library due to repeated System Error 322 occurrences.