FDA Enforcement
Class II
Terminated
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: Z-1628-2015
·
Reported May 27, 2015
Enforcement
- Recall Number
- Z-1628-2015
- Event ID
- 70946
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Baxter Corporation Englewood
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 27, 2015
- Initiation Date
- April 8, 2015
- Classification Date
- May 18, 2015
- Termination Date
- December 1, 2016
- Address
- 014445 Grasslands Dr, N/A, Englewood, CO, 80112-7062, United States
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
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.
Code Info
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,
Distribution
Worldwide Distribution - US Nationwide
Quantity
882