Date Initiated by Firm | April 16, 2003 |
Date Posted | May 14, 2003 |
Recall Status1 |
Terminated 3 on July 20, 2004 |
Recall Number | Z-0826-03 |
Recall Event ID |
26136 |
510(K)Number | K010068 |
Product Classification |
Prosthesis, Esophageal - Product Code ESW
|
Product | Polyflex Esophageal Stent 25/21mm x 150mm |
Code Information |
Reorder Number: M00514350 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 | 3 |
Distribution | Nationwide |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = ESW
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