Feb

2005

Baxter Healthcare Class II

Company: Baxter Healthcare
Date of Enforcement Report: 2/9/05
Class: II

PRODUCT
Logix-CM Compounder Software, catalog 2M8400. Recall # Z-0392-05.

REASON
A software anomaly in the Logix CM software could result in a drug mixture being compounded without one of the ingredients if two drugs have the same indentifier in Logix and another order entry program being used with the Logix software.

CODE
Software version 2.0.9 for Clintec Compounders.

RECALLING FIRM/MANUFACTURER
Baxter Healthcare, Corp, Round Lake, IL, by letters dated December 8, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
12 units.

DISTRIBUTION
MD, AZ, IN, OH, MN, PA, 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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Baxter Healthcare Class II

Amy Sellers

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