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.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. 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) and Italy.