Cl II Baxter ABACUS SE

Company: Baxter Corporation Englewood
Date of Enforcement Report: 5/27/2015
Class lI:

PRODUCT

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. Recall Number Z-1628-2015

REASON
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.

RECALLING FIRM/MANUFACTURER
Baxter Corporation Englewood, Englewood, CO on 4/8/2015 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
882

DISTRIBUTION
Nationwide

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