Company: Medex, Inc.
Date of Enforcement Report: 4/21/04
Class: III

PRODUCT
Medex 3000 Series Syringe Infusion Pumps.
Recall # Z-0813-04.

CODE
Model numbers: 3010 (General use pump for use with 3cc to 60cc syringes, 3010a (Pump for use with 1 cc to 60cc syringes), 3010aE (Use with 1cc to 60cc syringes in UK), 3010aVX (Evaluation pump for use with 1cc to 60cc syringes), 3010aZE (Refurbished pump for use with 1cc to 60cc syringes), 3010E (Pump for use with 3-60cc used in the UK), 3010SD (Model 3010 pump used for demonstrations), 3010VX (Evaluation pump for use with 3-60cc syringes), 3010E, 3500 (Pump with software for rapid occlusion detection and upper and lower programmable infusion dose limits), 3500BC (Not currently in distribution, 3500E (Pump with software for rapid occlusion detection and upper and lower programmable infusion dose limits used I the UK), 3500G (Pump with face plates and software for rapid occlusion detection and upper and lower programmable infusion dose limits in the German language), 3500SD (Model 3500 pump used for demonstrations, 3500VX (Evaluation pump with software for rapid occlusion detection and upper and lower programmable infusion dose limits.

RECALLING FIRM/MANUFACTURER
Medex, Inc., Duluth, GA, by letter starting on February 2, 2004. Firm initiated recall is ongoing.

REASON
Inadequate warning label: It is possible for an Extracorporeal Membrane Oxygenation (ECMO) circuit to generate high negative pressures on the inlet side.

VOLUME OF PRODUCT IN COMMERCE
7,896 units.

DISTRIBUTION
Nationwide, China, Hong Kong & UK.