Company: Harvard Clinical Technology
Date of Enforcement Report: 9/17/03
Class: II
PRODUCT
Harvard 2, Dual Infusion Pump (P/N 2002-001). Recall # Z-1208-03.
REASON
Under specific sequence conditions, the unit may appear to be infusing, but is not.
CODE
Software versions V1.2R or earlier.
RECALLING FIRM/MANUFACTURER
Harvard Clinical Technology, South Natick, MA, by letter on August 11, 2003. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
384 units.
DISTRIBUTION
Nationwide.
