Class II

Medical Device Recall: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2

Baxter Healthcare Corporation · November 19, 2024

Reason for Recall

Devices were identified as released after repair without full testing being performed, which includes flow testing.

Distribution

US Nationwide distribution in the states of AL, IN.

States Affected

NATIONWIDE

Quantity Affected

1 unit

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0776-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Baxter Healthcare Corporation Medical Device Recall: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2 | SafeCheck