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U.S. Department of Health and Human Services

Class 2 Device Recall Medfusion 3500

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 Class 2 Recall
Medfusion 3500
see related information
Date Posted April 26, 2007
Recall Status1 Open
Recall Number Z-0768-2007
Recall Event ID 37590
Premarket Notification
510(K) Number
K982640 
Product Classification Pump, Infusion - 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/
Manufacturer
Smiths Medical MD, Inc.
1265 Grey Fox Rd
Saint Paul, Minnesota 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
DESIGN: Software Design
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = MEDEX, INC.
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