Recall Z-1628-2015 ยท NEP System/Device, Pharmacy Compounding
Baxter Corporation Englewood
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.
| Date | May 18, 2015 (initiated Apr 8, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| 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 fca@baxter.com. For questions c |
| Quantity | 882 |
| Distribution | Worldwide Distribution - US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.