Company: Smiths Medical ASD, Inc.
Date of Enforcement Report 8/11//2010
Class ll:

PRODUCT
Medfusion Syringe Infusion Pumps, Models 3010 and 3010a with Software Versions 2.0.2, 2.0.3, AND 2.0.4 Medfusion Syringe Infusion Pumps are designed for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates. Recall # Z-2121-2010

REASON
Smiths Medical has found that pumps with obsolete software may continue to run past the set volume limit. This can result in an over-delivery if the syringe is over-filled. Smiths Medical has received no reports of serious patient injury or death related to this issue.

RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Saint Paul, MN, by letter dated June 11, 2010. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
4,816 units

DISTRIBUTION
Nationwide and Internationally