Home / Recalls / Baxter Corporation Englewood / Z-1566-2014

Z-1566-2014 Class I Terminated

Recalled by Baxter Corporation Englewood — Englewood, CO

Recall Details

Product Type
Devices
Report Date
May 21, 2014
Initiation Date
April 2, 2014
Termination Date
January 20, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2034

Product Description

ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition), 8300-0156 ABACUS 3.0 CE, 8300-0157 ABACUS 3.0 SE, 8300-0158 ABACUS 3.0 ME, 8300-0166 ABACUS 3.1 DE, 8300-0167 ABACUS 3.1 CE, 8300-0168 ABACUS 3.1 SE, 8300-0169 ABACUS 3.1 ME. ABACUS is a Windows - based order entry TPN software application for comprehensive calculations and label printing. The primary use of Abacus is for Total Parenteral Nutrition (TPN) order calculations.

Reason for Recall

1. ABACUS v3.1 may calculate quantities of electrolytes that are double the expected values during the creation of TPN orders. 2. ABACUS v3.1 may automatically add additional sterile water to a formula equal to the volume of a premix resulting in an over dilution. 3. All software versions of ABACUS software display the calcium phosphate curve points for Premasol incorrectly. 4. All software v

Distribution Pattern

Worldwide Distribution - USA nationwide, Canada, Colombia, Dominican Republic, Panama, Austria, Bosnia Herzegovina, Bulgaria, Bahrain, Estonia, France, Germany, Georgia, Hungary, Ireland, Israel, Jordan, Kuwait, Latvia, Morocco, Oman, Qatar, Saudi Arabia, Slovenia, Slovakia, South Africa, Switzerland, United Arab Emirates, United Kingdom, Hong Kong, and Taiwan.

Code Information

Product Code 8300-0045, 8300-0046, 8300-0047, 8300-0156, 8300-0157, 8300-0158, 8300-0166, 8300-0167, 8300-0168, 8300-0169

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-0539-2014 Class II — ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Edition), (December 3, 2013)