Date Initiated by Firm |
March 02, 2004 |
Date Posted |
March 19, 2012 |
Recall Status1 |
Terminated 3 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 2 |
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 and Original Applicant = AVAIL MEDICAL PRODUCTS, INC.
|