Company:Smiths Medical MD, Inc., .
Date of Enforcement Report:5/2/2007
Class:ll
PRODUCT
Medfusion 3500 Syringe Infusion Pump with PharmGuard Medication safety Software versions 4.1.3 and 4.1.4, Recall # Z-0768-2007
REASON
Software anomaly that causes the pump to experience a sudden and unexpected failure. This anomaly occurs during the pump’s startup sequence when the pump’s Preventative Maintenance Alarm goes off, preventing the pump from completing its power up routine. Lock-up occurs and the pump will not function.
CODE
Model 3500 pump with 4.1.4 or 4.1.3 software.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smiths Medical MD, Inc., Saint Paul, MN, by a ‘Customer Information Bulletin’ dated February 3, 2007 and a ‘Product Recall Notification’ dated February 16, 2007.
Manufacturer: Medex Inc, Duluth, GA. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
23,519 units
DISTRIBUTION
Nationwide, Canada and Italy
