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Medtronic MiniMed Paradigm Quick-set Plus Infusion Sets. Models MMT-359S6; MMT-359S9; MMT359L6; & MMT-359L9. (difference

FDA device recall Z-0910-04 · posted 2012-03-19 · Terminated

Recall details

Recalling firm
Medtronic MiniMed
Reason for recall
Possibility of interrupted insulin flow. This posting is for a recall that occurred in March 2004, also posted on the FDA website in 2004.
Action taken
Firm will ship all users (customers) one box at a 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.
Root cause
Component design/selection
Status
Terminated
Product code
FPA
Quantity affected
Undetermined
Distribution
Nationwide
Date initiated
2004-03-02
Date posted
2012-03-19
Date terminated
2012-03-19
Location
Northridge, CA

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Related 510(k) clearances

RecordFirmDate
MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, AND MMT-359L9 (K030149)Avail Medical Products, Inc.2003-03-20