FDA Recall
Terminated
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)
Recall: Z-0910-04
·
Initiated March 2, 2004
Recall
- Recall Number
- Z-0910-04
- Event Number
- 35768
- Firm
- Medtronic MiniMed
- FEI Number
- 3003166194
- Product Code
- FPA
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- March 2, 2004
- Posted
- March 19, 2012
- Terminated
- March 19, 2012
- Address
- 18000 Devonshire St, Northridge, CA, 91325-1219
Description
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)
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.
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.
Distribution
Nationwide
Quantity
Undetermined