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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmJune 25, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on August 23, 2004
Recall NumberZ-1106-04
Recall Event ID 29486
510(K)NumberK820867 
Product Classification Catheter, Nephrostomy, General & Plastic Surgery - Product Code GBO
ProductBoston Scientific brand Nephroureteral Stent System. Contents: 1-8Fr percuflex catheter with stent and locking pigtail, 1-stiffening cannula and 1-luer cap with septum. REF/catalog no. 90-6885; model no. M001906885.
Code Information Lots 6030323, exp. 01-Nov-06; 6348004, exp. 01-Mar-07 and 6313957, exp 01-Mar-07.
FEI Number 1828132
Recalling Firm/
Manufacturer		 Boston Scientific Corp
780 Brookside Dr
Spencer IN 47460-1080
For Additional Information ContactMarie Peters
508-652-5875
Manufacturer Reason
for Recall		Mislabeled as to size; 10FR are labeled as 8FR.
FDA Determined
Cause 2		Other
ActionThe firm hand delivered the recall notification to the consignee hospital on 6/30/04. Product at the customer have been relabeled by the firm.
DistributionMissouri.
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 = GBO
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