Home / Recalls / Baxter Corporation Englewood / Z-0539-2014

Z-0539-2014 Class II Terminated

Recalled by Baxter Corporation Englewood — Englewood, CO

Recall Details

Product Type
Devices
Report Date
December 25, 2013
Initiation Date
December 3, 2013
Termination Date
October 16, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,211

Product Description

ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition) ABACUS is a Windows¿ - based order entry TPN software application for comprehensive calculations and label printing. The primary use of Abacus is for TPN order calculations. Other uses of Abacus include: non-TPN volumes administered to patients on TPN therapy in order calculations; CVVH calculations; Cardioplegia (Buckburg) calculations; Epidural calculations; Dilutions from concentrated ingredient; Combinations of multiple ingredients; Fractional doses from larger volumes

Reason for Recall

Baxter Healthcare Corporation is issuing a voluntary correction for ABACUS Total parenteral Nutrition (TPN) Calculation Software versions 2.0 through 3.0 due to the possibility that a patient could receive another patient's TPN order as a result of data corruption.

Distribution Pattern

Nationwide Distribution

Code Information

Product Code: 8300-0045,,8300-0046,,8300-0047,,8300-0045,,8300-0046,,8300-0047,,8300-0045,,8300-0046,,8300-0047,,8300-0045,,8300-0046,,8300-0047,,8300-0045,,8300-0046,,8300-0047

Other recalls by Baxter Corporation Englewood

  • Z-0007-2017 Class I — 0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria (August 24, 2016)
  • Z-0731-2016 Class II — Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syring (December 21, 2015)
  • Z-1628-2015 Class II — ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) (April 8, 2015)
  • Z-1227-2015 Class II — Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Caps. (December 29, 2014)
  • Z-0871-2015 Class II — Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yell (December 4, 2014)
  • Z-1847-2014 Class II — Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations (May 28, 2014)
  • Z-1620-2014 Class II — RAPIDFILL Syringe Strip, For use with RAPIDFILL Automated Syringe Filler (ASF): (April 16, 2014)
  • Z-1566-2014 Class I — ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator (April 2, 2014)