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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm November 19, 2003
Date Posted December 24, 2003
Recall Status1 Terminated 3 on March 03, 2005
Recall Number Z-0265-04
Recall Event ID 27740
Product Classification Pump, Infusion, Insulin - Product Code LZG
Product Medtronic MiniMed Model 7311Version 5.0A Solutions Pumps and Meters Software
Code Information version 5.0A
Recalling Firm/
Manufacturer		 Medtronic MiniMed
18000 Devonshire St
Northridge CA 91325-1219
For Additional Information Contact Mark Faillace
818-576-5616
Manufacturer Reason
for Recall		 Accessory software fails to report certain reports following download of data from 712 pump.
FDA Determined
Cause 2		 Other
Action Sales personnel will visit each center and install the software and leave a CD. Or, instructions will be FEDEXed with a CD.
Quantity in Commerce 1020
Distribution Nationwide, Canada, Europe, Middle East and Africa
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.
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