Company:Baxa Corporation, Inc
Date of Enforcement Report:10/3/2007
Class:l
PRODUCT
Exacta-Mix 2400 OS v1.07, Model No. 8300-0073, Pharmacy Compounding System, Recall # Z-1238-2007
REASON
A software defect could allow up to 50mL of extra volume being added to a TPN (Total Parenteral Nutrition) solution.
RECALLING FIRM/MANUFACTURER
Baxa Corporation, Englewood, CO, by telephone and letter on June 27, 2007. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
30 units
DISTRIBUTION
CA, CO, FL, DY, MI, NY, OH, OR, and TX