Reported May 21, 2014 · Terminated
ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE…
Baxter Corporation Englewood
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Corporation Englewood · 14445 Grasslands Dr · Englewood, CO · 80112-7062
Is this the product you have?
- ABACUS TPN Calculation Software
- Product Codes8300-0045 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
- Lot codes and dates
Product Code 8300-00458300-00468300-00478300-01568300-01578300-01588300-01668300-01678300-01688300-0169
- Amount recalled
- 2034
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- GA
Why it was recalled
Stop using this product now
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
Using this product could cause serious injury, illness or death — stop using it now.
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