Z-1628-2015 Class II Terminated

Recalled by Baxter Corporation Englewood — Englewood, CO

Recall Details

Product Type
Devices
Report Date
May 27, 2015
Initiation Date
April 8, 2015
Termination Date
December 1, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
882

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Worldwide Distribution - US Nationwide

Code Information

Product Codes: 8300-0168 ,8300-0169 ,8300-0157 ,8300-0158 ,8300-0046 ,8300-0047 ,8300-0046 ,8300-0047 ,8300-0046 ,8300-0047 ,8300-0046 ,8300-0047,