ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) Product Usage: The ABACUS Software is a

FDA device recall Z-1628-2015 · posted 2015-05-18 · Terminated

Recall details

Recalling firm

Baxter Corporation Englewood

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.

Action taken

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 contact the Center for One Baxter at 800-422-9837.

Root cause

Software design

Status

Terminated

Product code

NEP

Quantity affected

882

Distribution

Worldwide Distribution - US Nationwide

Date initiated

2015-04-08

Date posted

2015-05-18

Date terminated

2016-12-01

Location

Englewood, CO