Z-1628-2015Class II

ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition)

Name: Z-1628-2015 ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition)
Creator: Baxter Corporation Englewood
Published: 2015-04-08
License: https://open.fda.gov/license/

Baxter Corporation Englewood / initiated 2015-04-08 / Terminated / root cause: software

FDA source

Baxter Corporation Englewood began a recall of ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) Product Usage: The ABACUS Software is a Windows-based order entry software... on 2015-04-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1628-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-08
Posted: 2015-05-18
Terminated: 2016-12-01
Recalling firm: Baxter Corporation Englewood
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.
Product code: NEP System/Device, Pharmacy Compounding
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.
Root cause tag: software
FDA 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 [email protected]. For questions contact the Center for One Baxter at 800-422-9837.
Quantity in commerce: 882
Distribution: Worldwide Distribution - US Nationwide
Product codes and lots: 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,

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1628-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1628-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-27	2015-05-18

Product code NEP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)