Class 2 Device Recall vanSonnenberg Sump

• Date Initiated by Firm: August 10, 2006
• Date Posted: September 13, 2006
• Recall Status: Terminated on February 07, 2007
• Recall Number: Z-1499-06
• Recall Event ID: 36136
• 510(K)Number: K811378
• Product Classification: drain - Product Code GBW
• Product: Boston Scientific vanSonnenberg Sump with ''J'' Tip, 30 cm, 14Fr (4.7 mm), for percutaneous abscess and fluid drainage, single use only, sterile; UPN M001202010, REF/Catalog No. 20-201.
• Code Information: Lot 8606405; exp. March 31, 2009.
• Recalling Firm/ Manufacturer: Boston Scientific Corp; 780 Brookside Dr; Spencer IN 47460-1080
• For Additional Information Contact: 508-683-4678
• Manufacturer Reason for Recall: Lack of assurance of sterility, as the sterile barrier is weak and may be damaged on one edge.
• FDA Determined Cause: Other
• Action: Consignee was notified via letter 8/10/06 to discontinue use of the product and to return it to the firm.
• Quantity in Commerce: 4 units
• Distribution: Texas.
• 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 = GBW and Original Applicant = MEDI-TECH, INC.