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U.S. Department of Health and Human Services

Class 1 Device Recall

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 Class 1 Device Recallsee related information
Date Initiated by FirmMarch 02, 2004
Create DateJuly 20, 2004
Recall Status1 Open3, Classified
Recall NumberZ-0910-04
Recall Event ID 28448
ProductMedtronic MiniMed Paradigm Quick-set Plus Infusion Sets. Models MMT-359S6; MMT-359S9; MMT-359L6 and MMT-359L9. (Differences in models is variation in length, 6 versus 9 MM.)
Code Information All lots.
Recalling Firm/
Manufacturer		 Medtronic MiniMed
18000 Devonshire St
Northridge 91325-1219
For Additional Information ContactMark Faillace
818-576-5616
Manufacturer Reason
for Recall		Possibility of interrupted insulin flow.
ActionFirm will ship all users (customers) one box at at time every three weeks for the next several months. A recall notification letter was issued to users and to healthcare professionals, and distributors. Letters were mailed from March 2-5, 2004.
Quantity in Commerce1,676,546 units
DistributionNationwide
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.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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