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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm May 10, 2006
Date Posted July 13, 2006
Recall Status1 Terminated 3 on November 01, 2006
Recall Number Z-1238-06
Recall Event ID 35494
510(K)Number K010002  
Product Classification Stent, Ureteral - Product Code FAD
Product Boston Scientific Contour VL Injection Stent with Hydro Plus Coating, 6 FR (2.0 mm) x 22-30 cm (220-300mm), sterile, UPN: M0061856300. Ureteral stent.
Code Information Lot 8473180.
Recalling Firm/
Manufacturer		 Boston Scientific Corp
780 Brookside Dr
Spencer IN 47460-1080
For Additional Information Contact
800-862-1284
Manufacturer Reason
for Recall		 Instructions on how to inject are not included in the package.
FDA Determined
Cause 2		 Other
Action A letter dated 5/10/06 was sent to each consignee requesting that they discontinue use of, and return, the product.
Quantity in Commerce 29
Distribution New York and Pennsylvania.
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 = FAD and Original Applicant = BOSTON SCIENTIFIC CORP.
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