Recall Z-1628-2015— Baxter Corporation Englewood
Class II · Terminated
Class II FDA medical device recall by Baxter Corporation Englewood, initiated 2015-04-08, terminated 2016-12-01. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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
- Baxter Corporation Englewood
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-08
- Terminated
- 2016-12-01
- Firm location
- Englewood, CO, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.