09
Feb
2005

Baxter Healthcare Class II

0

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

PRODUCT
Logix-CM Compounder Software, catalog 2M8400. Recall # Z-0394-05.

REASON
Logix-CM software version 3.0.4 has not completed its official release process.

CODE
Software version 3.0.4.

RECALLING FIRM/MANUFACTURER
Baxter Healthcare, Corp, Round Lake, IL, by letters dated December 20, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
5 units.

DISTRIBUTION
AZ, UT, NC, WI, and CA.

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.

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