Class 2 Device Recall ACCUSTICK II

• Date Initiated by Firm: July 19, 2007
• Date Posted: December 07, 2007
• Recall Status: Terminated on February 17, 2008
• Recall Number: Z-0328-2008
• Recall Event ID: 38471
• 510(K)Number: K952828
• Product Classification: Catheter Introducer - Product Code DYB
• Product: Boston Scientific ACCUSTICK II Introducer System with .038 inch Stainless Steel J Tip and .018 inch Nitinol Guidewire, sterile, REF/Catalog No. 20-710; UPN/Material Number: M001207100, Boston Scientific Corporation, Natick, MA 01760
• Code Information: Lot /Batch Number: 9498023.
• Recalling Firm/ Manufacturer: Boston Scientific Corp; 780 Brookside Dr; Spencer IN 47460-1080
• For Additional Information Contact: 508-683-4433
• Manufacturer Reason for Recall: Marker Detachment: Out of specifications for pull strength, thus the marker may detach from the introducer during use.
• FDA Determined Cause: Process control
• Action: Consignees were notified via an Urgent Medical Device Recall Letter sent federal express on 7/19/07, which requested them to check their stocks, remove product from inventory, and return the product.
• Quantity in Commerce: 249 (199 U.S.A. plus 50 international)
• Distribution: Worldwide: USA and The Netherlands.
• 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 = DYB