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U.S. Department of Health and Human Services

Class 2 Device Recall Stonetome

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  Class 2 Device Recall Stonetome see related information
Date Initiated by Firm May 19, 2006
Date Posted June 27, 2006
Recall Status1 Terminated 3 on June 20, 2007
Recall Number Z-1114-06
Recall Event ID 35535
510(K)Number K946358  
Product Classification Dislodger, Stone, Biliary - Product Code LQR
Product Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 30 mm cut wire, proximal balloon, sterile, single use only, material number M00535210; catalog number 3521.
Code Information All lots. Lots 6604751, 6689295, 6802779, 6848203, 6905391, 7053955, 7098448, 7189064, 7353544, 7442998, 7592642, 7676907, 7703438, 7802899, 7852756, 7938900, 8002453, 8271737 and 8502059.
Recalling Firm/
Manufacturer
Boston Scientific Corp
780 Brookside Dr
Spencer IN 47460-1080
For Additional Information Contact
800-862-1284
Manufacturer Reason
for Recall
Lack of assurance of sterility, as the sterile barrier may fail.
FDA Determined
Cause 2
Other
Action Consignees were notified to cease using, and to return, the products via recall letter dated May 19, 2006. International customers were also notified.
Distribution Nationwide, Arab Emirate, Australia, Austria, Belgium, Canada, Denmark, Finland, France, germany, Great Britain, Hong Kong, Israel, Italy, Japan, Libya, Mexico, Netherlands, New Zealand, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey, Taiwan, Venezuela and Viet Nam.
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 = LQR and Original Applicant = BOSTON SCIENTIFIC CORP.
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