CLASS I Device recall · Reported 21 May 2014 · FDA Enforcement Report
Abacus TPN Calculation recalled by Baxter Corporation Englewood
Baxter Corporation Englewood is recalling Abacus TPN Calculation, distributed nationwide in the US. The recall was initiated on 2 Apr 2014 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1566-2014
- FDA event ID
- 67884
- Recalling firm
- Baxter Corporation Englewood, Englewood, CO
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 2 Apr 2014
- FDA classified
- 12 May 2014
- Reported
- 21 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Medical Software
Timeline
| 2 Apr 2014 | Recall initiated by company | |
| 12 May 2014 | Classified by FDA | +40 days |
| 21 May 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
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.
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Product Code 8300-0045, 8300-0046, 8300-0047, 8300-0156, 8300-0157, 8300-0158, 8300-0166, 8300-0167, 8300-0168, 8300-0169
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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