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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmJune 02, 2005
Date PostedJuly 07, 2005
Recall Status1 Terminated 3 on December 13, 2006
Recall NumberZ-0971-05
Recall Event ID 32383
510(K)NumberK910584 
Product Classification Tube, Gastro-Enterostomy - Product Code KGC
ProductBoston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 24/3.4 push; catalog number 6852.
Code Information Lots 7467759, 7434810, 7477229, 7434811 and 7401901.
Recalling Firm/
Manufacturer		 Boston Scientific Corp
780 Brookside Dr
Spencer IN 47460-1080
For Additional Information ContactKathy 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
ActionCustomers were notified by a recall letter dated 6/7/05 which instructed them to return any of the recalled products on hand.
DistributionNationwide and Panama.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KGC
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