Company:Baxa Corp.
Date of Enforcement Report 4/18/12
Class ll:

PRODUCT
Pharmacy compounding system. It is a twenty-four source compounder for multi-source fluid mixing of both macro and micro ingredient down to 0.2 ml quantities. Product Usage: Pharmacy compounding System for parenteral macro and micro ingredients. 2 model numbers 2400 D and 2400 M. Recall # Z-1389-2012

REASON
Software issue with compounding pump resulting in over delivery of component ingredients during routine operations.

RECALLING FIRM/MANUFACTURER
Baxa Corp., Englewood, CO, by letter dated March 23, 2009. Firm iInitiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1322 units

DISTRIBUTION
Nationwide and Canada