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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 3500see related information
Date Initiated by FirmFebruary 03, 2007
Date PostedApril 26, 2007
Recall Status1 Terminated 3 on February 10, 2011
Recall NumberZ-0768-2007
Recall Event ID 37590
510(K)NumberK982640 
Product Classification Infusion Pump - Product Code FRN
ProductMedfusion 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/
Manufacturer		 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		Other
ActionConsignees 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 Commerce23,519
DistributionNationwide, Canada, and Italy.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FRN
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