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U.S. Department of Health and Human Services

Class 2 Device Recall vanSonnenberg Sump

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  Class 2 Device Recall vanSonnenberg Sump see related information
Date Initiated by Firm August 10, 2006
Date Posted September 13, 2006
Recall Status1 Terminated 3 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/
Boston Scientific Corp
780 Brookside Dr
Spencer IN 47460-1080
For Additional Information Contact
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 2
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.