FDA Recall 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 · Initiated April 8, 2015

Recall

Recall Number
Z-1628-2015
Event Number
70946
Firm
Baxter Corporation Englewood
FEI Number
1419106
Product Code
NEP
Status
Terminated
Root Cause
Software design
Initiated
April 8, 2015
Posted
May 18, 2015
Terminated
December 1, 2016
Address
014445 Grasslands Dr, Englewood, CO, 80112-7062

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.

Action

Baxter sent a Safety Alert letter dated April 8, 2015 to affected customers via USPS first class mail. The letter identified the affected product, problem and actions to be taken. Customers were asked to 1) contact Baxter Technical Services if you need to restore the ABACUS databse, 2) foword a copy of this Safety Alert letter to other facilities or departments within your institution to ensure that those locations are awae of this action, and 3) complete the customer reply form and return it to Baxter by faxing to 224-270-5457 or scanning and e-mailing it to [email protected]. For questions contact the Center for One Baxter at 800-422-9837.

Distribution

Worldwide Distribution - US Nationwide

Quantity

882