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U.S. Department of Health and Human Services

Class 2 Device Recall Medfusion 3500

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  Class 2 Device Recall Medfusion 3500 see related information
Date Initiated by Firm February 03, 2007
Date Posted April 26, 2007
Recall Status1 Terminated 3 on February 10, 2011
Recall Number Z-0768-2007
Recall Event ID 37590
510(K)Number K982640  
Product Classification Infusion Pump - Product Code FRN
Product Medfusion 3500 Syringe Infusion Pump with PharmGuard Medication safety Software versions 4.1.3 and 4.1.4. Medex, 4350 Green Parkway, Suite 200. Duluth, GA 30096
Code Information Model 3500 pump with 4.1.4 or 4.1.3 software.
Recalling Firm/
Smiths Medical MD, Inc.
1265 Grey Fox Rd
Saint Paul MN 55112-6929
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Action Consignees were initially notified of the recall via a Customer Information Bulletin which was sent via electronic mail 2/3/07 and confimed with a telephone conversation. A Product Recall Notification and a Product Recall Bulletin will be sent to all consignees via the mail on 2/16/07.
Quantity in Commerce 23,519
Distribution Nationwide, Canada, and Italy.
Total Product Life Cycle TPLC Device Report

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.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = MEDEX, INC.