Class 2 Device Recall

• Date Initiated by Firm: October 28, 2005
• Date Posted: January 06, 2006
• Recall Status: Terminated on February 15, 2007
• Recall Number: Z-0343-06
• Recall Event ID: 33858
• 510(K)Number: K991897
• Product Classification: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
• Product: Implantable Chest Ports labeled: Titanium Single Lumen Port with PASV valve and 6.6F Silicone Catheter. Boston Scientific Cat. # PRTA66P M001PRTA66P0. Firm on label: Boston Scientific Natick, MA and Boston Scientific Corp., Glens Falls, NY.
• Code Information: 1011815, 1020902, 1021341, 1021634
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 1 Boston Scientific Pl; Natick MA 01760-1536
• For Additional Information Contact: Cindy Finney; 508-683-4678
• Manufacturer Reason for Recall: Device kits contain B. Braun Locking Tearaway Introducer Systems labeled as 7Fr but may contain 8 Fr sheaths.
• FDA Determined Cause: Other
• Action: Boston Scientific letter dated 10/28/2005 sent via Federal Express. Customers (hospitals) instructed to remove and return product.
• Quantity in Commerce: 50 units
• Distribution: DOMESTIC: Nationwide distribution. FOREIGN: Spain, France, Italy, Great Britain, Sweden, Jordan
• 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 = LJS and Original Applicant = CATHETER INNOVATIONS, INC.