Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Stonetome

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Stonetomesee related information
Date Initiated by FirmMay 19, 2006
Date PostedJune 27, 2006
Recall Status1 Terminated 3 on June 20, 2007
Recall NumberZ-1112-06
Recall Event ID 35535
510(K)NumberK946358 
Product Classification Dislodger, Stone, Biliary - Product Code LQR
ProductBoston Scientific Stonetome Stone Removal Device, 20 mm tip, 20 mm cut wire, proximal balloon, sterile, single use only, material number M00535170; catalog number 3517.
Code Information All lots. Lots 6546667, 6602514, 6706832, 6763251, 6811777, 6848204, 6930829, 7022531, 7078442, 7172641, 7283354, 7375263, 7467937, 7620507, 7725395, 7752678, 8037806, 8133510, 8230614, 8331439, 8360757, 8360758, 8384930, 8384931, 8411892, 8411893, 8411894, 8411895 and 8534126.
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
ActionConsignees were notified to cease using, and to return, the products via recall letter dated May 19, 2006. International customers were also notified.
DistributionNationwide, 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 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 = LQR
-
-