Baxter Corporation Englewood recalls ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) Product Usage: The ABACUS Software is…

Recall date

April 8, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1628-2015

FDA classification

Class II

Brand / firm

Baxter Corporation Englewood

Sold / distributed

Worldwide Distribution - US Nationwide

Why it was recalled

Baxter Corporation is conducting a field action for the ABACUS SE and ME models due to the possibility that the compounder will load the incorrect formula upon scanning the bag label when two or more different formula files have been created with the same order number.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) Product Usage: The ABACUS Software is a Windows-based order entry software application for comprehensive total parenteral nutrition (TPN) calculations and label printing.