Class 3 Device Recall

• Date Initiated by Firm: May 10, 2006
• Date Posted: July 13, 2006
• Recall Status: Terminated on November 01, 2006
• Recall Number: Z-1238-06
• Recall Event ID: 35494
• 510(K)Number: K010002
• Product Classification: Stent, Ureteral - Product Code FAD
• Product: Boston Scientific Contour VL Injection Stent with Hydro Plus Coating, 6 FR (2.0 mm) x 22-30 cm (220-300mm), sterile, UPN: M0061856300. Ureteral stent.
• Code Information: Lot 8473180.
• Recalling Firm/ Manufacturer: Boston Scientific Corp; 780 Brookside Dr; Spencer IN 47460-1080
• For Additional Information Contact: 800-862-1284
• Manufacturer Reason for Recall: Instructions on how to inject are not included in the package.
• FDA Determined Cause: Other
• Action: A letter dated 5/10/06 was sent to each consignee requesting that they discontinue use of, and return, the product.
• Quantity in Commerce: 29
• Distribution: New York and Pennsylvania.
• 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 = FAD