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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm June 02, 2005
Date Posted July 07, 2005
Recall Status1 Terminated 3 on December 13, 2006
Recall Number Z-0967-05
Recall Event ID 32383
510(K)Number K031538  
Product Classification Tubes, Gastrointestinal (And Accessories) - Product Code KNT
Product Boston Scientific brand pull Gastro-dome (percutaneous endoscopic gastrostomy tubes) Kit, 20 Frl; catalog number 6838.
Code Information Lots 7452729, 7448186, 7426909 and 7385202.
Recalling Firm/
Manufacturer		 Boston Scientific Corp
780 Brookside Dr
Spencer IN 47460-1080
For Additional Information Contact Kathy Thorp
508-683-4026
Manufacturer Reason
for Recall		 Two blades may be heat staked onto the stiletto instead of the expected one blade.
FDA Determined
Cause 2		 Other
Action Customers were notified by a recall letter dated 6/7/05 which instructed them to return any of the recalled products on hand.
Distribution Nationwide and Panama.
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 = KNT and Original Applicant = BOSTON SCIENTIFIC CORP.
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