Date Initiated by Firm |
April 16, 2003 |
Date Posted |
May 14, 2003 |
Recall Status1 |
Terminated 3 on July 20, 2004 |
Recall Number |
Z-0823-03 |
Recall Event ID |
26136 |
510(K)Number |
K010068
|
Product Classification |
Prosthesis, Esophageal - Product Code ESW
|
Product |
Polyflex Esophageal Stent 23/18mm x 150mm |
Code Information |
Reorder Number: M00514320 Lot Numbers: 03101, 03071 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 1 Boston Scientific Place Natick MA 01760
|
For Additional Information Contact |
Robert T. Miragliulo 508-652-35186
|
Manufacturer Reason for Recall |
Radiopaque marker bands may not be visible under fluoroscopy
|
FDA Determined Cause 2 |
Other |
Action |
Boston Scientific notified domestic accounts by letter on April 16, 2003. The account wasinstructed to check inventory and return product. A Reply Verification form was provided to document amount of product in inventory. |
Quantity in Commerce |
5 |
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 = ESW and Original Applicant = RUSCH INTL.
|