Date Initiated by Firm |
March 17, 2003 |
Date Posted |
April 17, 2003 |
Recall Status1 |
Terminated 3 on March 07, 2016 |
Recall Number |
Z-0740-03 |
Recall Event ID |
25812 |
510(K)Number |
K830840
|
Product Classification |
Catheter, Urethral - Product Code GBM
|
Product |
Boston Scientific/Microvasive Open End Ureteral Catheter (6 Fr x 70 cm) Product Number: 400-202 |
Code Information |
Lot Numbers: 5161012 5174860 5174861 5180481 5185487 5218431 5221729 5243192 5243192 5252957 5296861 5296862 5303657 5327920 5327921 5327921 5345290 5348157 5355947 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 1 Boston Scientific Place Natick MA 01760
|
For Additional Information Contact |
Robert T. Miragliulo 508-652-5186
|
Manufacturer Reason for Recall |
Warning flag may be detached from the tip protector on the catheter and result in the tip protector advancing through the catheter during use
|
FDA Determined Cause 2 |
Other |
Action |
Boston Scientific/Microvasive, Natick, MA notified domestic accounts by letter on 3/17/03. Users are requesed to check inventory and return product to Boston Scientific. A responsed form was requested to be completed. and returned by facsmile. |
Quantity in Commerce |
72 boxes (20 units/box) |
Distribution |
Nationwide
Foreign:Singapore, Japan, Korea, Canada, Africa |
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 = GBM and Original Applicant = VAN-TEC, INC.
|