Sep

2008

Cl Il Baxter Logix TPN Software Solution

Company: Baxter Healthcare Corp
Date of Enforcement Report 9/30/2008
Class:ll

PRODUCT
Logix TPN Software Solution, catalog 2M8410, consists of the Logix Order Entry (OE) Installation CD, version 1.0.28 and Logix Compounder Manager (CM) Installation CD, version 3.1.8. The software is included in a number of Baxter’s pharmacy compounders. The software assists the pharmacist in management of compounding, creating and authorizing nutritional solutions intended for IV administration, Recall # Z-1640-2008

REASON
Software anomaly results in inaccurate information being printed out on the Delivery Report, even though the compounder performed the compounding correctly.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare, Corp., Round Lake, IL, by letter on March 28, 2008.
Manufacturer: Baxter Healthcare Corp., Buffalo Grove, IL. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
5 units

DISTRIBUTION
AZ, MN, WI, PR and Canada

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl Il Baxter Logix TPN Software Solution

Amy Sellers

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