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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System

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  Class 2 Device Recall Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System see related information
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 and Original Applicant = Boston Scientific Corporation
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