Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0197-2014 — SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.

U.S. FDA — Device Enforcement · United States · 2013-06-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0197-2014
Date of alert
2013-06-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Baxter Healthcare Corp.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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