FDA Device recall Z-0197-2014
SIGMA SPECTRUM Infusion Pump with Master Drug Library
- FDA Device
- Class II
- terminated
- Published 2013-11-20
On 2013-11-20 the FDA classified a Class II recall of SIGMA SPECTRUM Infusion Pump with Master Drug Library by Baxter Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0197-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-10 |
| Published | 2013-11-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Baxter Healthcare |
| Distribution | PR |
Product
SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.
Reason
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.
Identifiers
| code_info | Product Code: 35700BAX, 35700ABB Serial Numbers: All |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0197-2014%22
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