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Z-1484-2014 Class I Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA device recall Z-1484-2014 was initiated by Baxter Healthcare Corp. on Feb 7, 2014 and is designated Class I. Reason for recall: 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. The recall status is terminated (terminated May 25, 2017). Affected quantity: 277,096 units (revised).

Recall Details

Product Type: Devices
Report Date: Apr 30, 2014
Initiation Date: Feb 7, 2014
Termination Date: May 25, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 277,096 units (revised)

Product Description

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.

Reason for Recall

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.

Distribution Pattern

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

Code Information

Product Codes: 35700BAX, 35700ABB

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1484-2014
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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