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/ 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 |
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.
|