Baxter Healthcare Corp Class I

Company: Baxter Healthcare Corp
Date of Enforcement Report: 8/14/02
Class: I

PRODUCT
Logix-CM Compounder Software. Recall # Z-1203-2.

REASON
Software allows ingredient concentration errors during compounding.

CODE
Catalog #2M8400, Logix-CM software version 1.0.2.

RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corp., Round Lake, IL, by telephone on June 18, 2002. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
4 units.

DISTRIBUTION
NC, UT, AZ and WI.

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

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QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
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Corporate Office

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