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Class 2 Device Recall |
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Date Initiated by Firm |
February 16, 2004 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on November 07, 2005 |
Recall Number |
Z-0813-04 |
Recall Event ID |
28699 |
Product Classification |
unknown device name - Product Code CAJ
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Product |
Medex 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. |
Recalling Firm/ Manufacturer |
Medex Inc 4350 River Green Pkwy Ste 200 Duluth GA 30096-8321
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For Additional Information Contact |
Terri Davis 800-848-1757 Ext. 5542
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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.
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FDA Determined Cause 2 |
Other |
Action |
Consignees were notified by letter starting 2/2004 and continues to the present |
Quantity in Commerce |
7896 units |
Distribution |
Nationwide, China, Hong Kong & UK |
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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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