Date Initiated by Firm | March 18, 2016 |
Create Date | April 25, 2016 |
Recall Status1 |
Terminated 3 on August 26, 2016 |
Recall Number | Z-1567-2016 |
Recall Event ID |
73660 |
510(K)Number | K141584 |
Product Classification |
Prosthesis, tracheal, expandable - Product Code JCT
|
Product | Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm
Material Number: M00576550
The stent system is a permanently implanted expandable metal stent designed for palliation of tracheobronchial (TB) strictures. The system consists of a flexible delivery catheter preloaded with an expandable metal stent. The stent is offered in a variety of sizes of different diameters and lengths |
Code Information |
Lot Number: 18876596 Exp Date: February 1, 201 8 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 100 Boston Scientific Way Marlborough MA 01752-1234
|
For Additional Information Contact | SAME 508-382-9555 |
Manufacturer Reason for Recall | Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm diameter x 30mm |
FDA Determined Cause 2 | Process control |
Action | Boston Scientific issued notification letters dated March 17, 2016. The notification instructs the customer to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form. Customers with questions should call 866-868-4004. For questions regarding this recall call 508-382-9555. |
Quantity in Commerce | 4 units |
Distribution | Nationwide Distribution to AL, CA, MA, and TX. |
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 = JCT
|