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