Date Initiated by Firm |
June 10, 2005 |
Date Posted |
June 25, 2005 |
Recall Status1 |
Terminated 3 on November 17, 2005 |
Recall Number |
Z-0935-05 |
Recall Event ID |
32459 |
510(K)Number |
K033314
|
Product Classification |
Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
|
Product |
ev3 Protege GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System). Model No. SERB65-08-20-120 ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. Sterile EO. Single Use. |
Code Information |
1179167 |
Recalling Firm/ Manufacturer |
Ev3 4600 Nathan Ln N Plymouth MN 55442-2890
|
For Additional Information Contact |
Michael D. Geary 763-398-7546
|
Manufacturer Reason for Recall |
A total of 3 devices from 3 separate lots were re-labeled with incorrect stent dimensions (diameter and length) and distributed to 2 hospitals. Affected product was retrieved by an ev3 representative.
|
FDA Determined Cause 2 |
Other |
Action |
ev3 representative went to the 2 hospitals to retrieve affected product on 06/10/05, completed a Field Action Form and left a copy with the hospital. |
Quantity in Commerce |
1 |
Distribution |
FL and PA |
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 = FGE and Original Applicant = EV3 INC
|