Class 3 Device Recall

• Date Initiated by Firm: June 18, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on December 14, 2004
• Recall Number: Z-1102-04
• Recall Event ID: 29418
• 510(K)Number: K834468
• Product Classification: Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
• Product: Boston Scientific/Microvasive brand Biliary Stent Kit, 7 FR x 5 cm, sterile, single use only; Ref 3101.
• Code Information: Lot 6419084.
• FEI Number: 1828132
• Recalling Firm/ Manufacturer: Boston Scientific Corp; 780 Brookside Dr; Spencer IN 47460-1080
• For Additional Information Contact: 800-862-1284
• Manufacturer Reason for Recall: Mislabeled as to length; 10 cm length labeled as 5 cm.
• FDA Determined Cause: Other
• Action: Consignees were notified via recall letter dated June 18, 2004. Consignees were instructed to call the firm if they had any product in stock.
• Distribution: California, Hawaii, Kentucky, New Jersey and Oregon.
• 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 = FGE