Recall Z-0910-04 ยท FPA Set, Administration, Intravascular
Medtronic MiniMed
Medtronic MiniMed Paradigm Quick-set Plus Infusion Sets. Models MMT-359S6; MMT-359S9; MMT359L6; & MMT-359L9. (differences in models is variation in length, 6 versus 9mm)
| Date | Mar 19, 2012 (initiated Mar 2, 2004) |
| Status | Terminated |
| Reason | Possibility of interrupted insulin flow. This posting is for a recall that occurred in March 2004, also posted on the FDA website in 2004. |
| Root cause | Component design/selection |
| Action | 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. |
| Quantity | Undetermined |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030149 | MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, AND MMT-359L9 Avail Medical Products, Inc., Mar 20, 2003 |