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

Recall Z-1484-2014 — 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

U.S. FDA — Device Enforcement · United States · 2014-02-07 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1484-2014
Date of alert: 2014-02-07
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Baxter Healthcare Corp.
Product category: device
Product type: Devices

Reported risk: 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.

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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