Z-1628-2015 Class II Terminated
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,