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 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.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.