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Z-0197-2014 Class II Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA device recall Z-0197-2014 was initiated by Baxter Healthcare Corp. on Jun 10, 2013 and is designated Class II. Reason for recall: Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Drug Library due to reports of upstream occlusion alarms and air-in-line alarms… The recall status is terminated (terminated Apr 20, 2017). Affected quantity: 273,835 units.

Recall Details

Product Type: Devices
Report Date: Nov 20, 2013
Initiation Date: Jun 10, 2013
Termination Date: Apr 20, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 273,835 units

Product Description

SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.

Reason for Recall

Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Drug Library due to reports of upstream occlusion alarms and air-in-line alarms occurring during infusions.

Distribution Pattern

Worldwide Distribution-USA including Puerto Rico and Canada.

Code Information

Product Code: 35700BAX, 35700ABB Serial Numbers: All

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0197-2014
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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