CLASS II Device recall · Reported 25 Dec 2013 · 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 3 Dec 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct 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

Quantity recalled2,211

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-0539-2014
FDA event ID: 66989
Recalling firm: Baxter Corporation Englewood, Englewood, CO
Classification: Class II
Status: Terminated
Recall initiated: 3 Dec 2013
FDA classified: 18 Dec 2013
Reported: 25 Dec 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

3 Dec 2013	Recall initiated by company
18 Dec 2013	Classified by FDA	+15 days
25 Dec 2013	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Nationwide Distribution

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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.

More recalls from Baxter Corporation Englewood

All 9

Reported	Class	Recall	Company	Reason	Where
12 Oct 2016Device	CLASS I	0.2 Micron Filter recalled by Baxter Corporation Englewood	Baxter Corporation Englewood	Particulate Matter	Nationwide
10 Feb 2016Device	CLASS II	Baxter, Rapidfill Syringe Strip For use recalled	Baxter Corporation Englewood	Packaging Defects	Nationwide
27 May 2015Device	CLASS II	Abacus SE (Single-Workstation Edition) and Abacus ME recalled	Baxter Corporation Englewood	Device Malfunction	Nationwide
11 Mar 2015Device	CLASS II	Baxter, Self-Righting Syringe Tip Caps recalled	Baxter Corporation Englewood	Other	Nationwide
31 Dec 2014Device	CLASS II	Self-Righting Luer Lock Tip Cap, Green recalled	Baxter Corporation Englewood	Foreign Material	4 states

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