Recall Z-0539-2014— Baxter Corporation Englewood

Class II FDA medical device recall by Baxter Corporation Englewood, initiated 2013-12-03, terminated 2015-10-16. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..

Recalling firm

Baxter Corporation Englewood

Classification

Class II

Status

Terminated

Initiated

2013-12-03

Terminated

2015-10-16

Firm location

Englewood, CO, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.