Class 1 Device Recall Medtronic MiniMed Paradigm Quickset Plus Infusion Sets

• Date Initiated by Firm: March 02, 2004
• Date Posted: March 19, 2012
• Recall Status: Terminated on March 19, 2012
• Recall Number: Z-0910-04
• Recall Event ID: 35768
• 510(K)Number: K030149
• Product Classification: Infusion Set - Product Code FPA
• Product: 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)
• Code Information: All lots
• Recalling Firm/ Manufacturer: Medtronic MiniMed; 18000 Devonshire St; Northridge CA 91325-1219
• For Additional Information Contact: Mark Faillace; 818-576-5616
• Manufacturer 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.
• FDA Determined 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 in Commerce: Undetermined
• Distribution: Nationwide
• Total Product Life Cycle: TPLC Device Report

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.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FPA