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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmFebruary 16, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on November 07, 2005
Recall NumberZ-0813-04
Recall Event ID 28699
Product Classification unknown device name - Product Code CAJ
ProductMedex 3000 Series Syringe Infusion Pumps
Code Information 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.
FEI Number 1036813
Recalling Firm/
Manufacturer		 Medex Inc
4350 River Green Pkwy Ste 200
Duluth GA 30096-8321
For Additional Information ContactTerri Davis
800-848-1757 Ext. 5542
Manufacturer Reason
for Recall		Inadequate warning label: Medex has determined that it is possible for an Extracorporeal Membrane Oxygenation (ECMO) circuit to generate high negative pressures on the inlet side.
FDA Determined
Cause 2		Other
ActionConsignees were notified by letter starting 2/2004 and continues to the present
Quantity in Commerce7896 units
DistributionNationwide, China, Hong Kong & UK
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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