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Class 2 Device Recall Stonetome |
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Date Initiated by Firm |
May 19, 2006 |
Date Posted |
June 27, 2006 |
Recall Status1 |
Terminated 3 on June 20, 2007 |
Recall Number |
Z-1111-06 |
Recall Event ID |
35535 |
510(K)Number |
K946358
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Product Classification |
Dislodger, Stone, Biliary - Product Code LQR
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Product |
Boston Scientific Stonetome Stone Removal Device, 5 mm tip, 20 mm cut wire, proximal balloon, sterile, single use only, material number M00535150; catalog number 3515. |
Code Information |
All lots. Lots 603391, 6799504, 7037095, 7403583, 7747718, 8005961, 8358477, 6539142, 6800398, 7049985, 7416358, 7760416, 8017560, 8358478, 6546666, 6817098, 7049986, 7417916, 7761394, 8018138, 8379614, 6553801, 6817103, 7053803, 7435843, 7761853, 8032106, 8388053, 6553902, 6828542, 7066018, 7441770, 7786226, 8032115, 8400748, 6565305, 6828544, 7079432, 7462728, 7786735, 8051884, 8400749, 6573305, 6846542, 7097700, 7462729, 7802332, 8056988, 8422201, 6573599, 6846543, 7097887, 7468203, 7807099, 8071999, 8422445, 6591126, 6854647, 7119562, 7485762, 7814339, 8072078, 8423915, 6600353, 6856256, 7119563, 7490850, 7819437, 8093644, 8428272, 6603310, 6866068, 7135244, 7510077, 7834051, 8098020, 8450926, 6612042, 6866800, 7137004, 7510139, 7836780, 8098242, 8452464, 6622542, 6866801, 7143070, 7529920, 7844585, 8109397, 8465129, 6624628, 6880631, 7162295, 7529921, 7850336, 8109398, 8465132, 6639865, 6880632, 7171662, 7549824, 7852743, 8119584, 8481185, 6639866, 6882924, 7172639, 7561807, 7870482, 8129662, 8481186, 6642282, 6882925, 7194509, 7570701, 7870483, 8129666, 8502291, 6654412. 6882926, 7196785, 7580070, 7874768, 8142554, 8502292, 6654414, 6905787, 7215344, 7596810, 7874769, 8146781, 8529548, 6655006, 6905789, 7226282, 7601687, 7888575, 8151220, 8529873, 6688430, 6928345, 7230675, 7614631, 7889310, 8151399, 8534044, 6688431, 6930039, 7230717, 7622178, 7893150, 8162009, 8551812, 6705783, 6930823, 7240370, 7636172, 7900338, 8165618, 6706029, 6930828, 7255850, 7644297, 7903556, 8185320, 6706030, 6944021, 7255852, 7644959, 7907510, 8206062, 6722148, 6944023, 7281821, 7660740, 7919430, 8206395, 6722149, 6945019, 7283356, 7669404, 7919806, 8229567, 6723458, 6965086, 7298816, 7685490, 7924565, 8229568, 6742385, 6965087, 7309412, 7685991, 7940070, 8241697, 6742386, 6965092, 7321591, 7696885, 7947076, 8241698, 6742387, 6987554, 7321593, 7697518, 7947978, 8262517, 6761469, 6987555, 7343776, 7709157, 7969329, 8272091, 6761470, 7005426, 7344057, 7717440, 7971757, 8307578, 6771563, 7008933, 7367660, 7733590, 7978424, 8319259, 6771840, 7009025, 7367661, 7742542, 7978758, 8331425, 6780209, 7026602, 7392895, 7745771, 7997846, 8341585, 6799502, 7035326, 7392896, 7747717, 8002443 and 8341586. |
Recalling Firm/ Manufacturer |
Boston Scientific Corp 780 Brookside Dr Spencer IN 47460-1080
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For Additional Information Contact |
800-862-1284
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Manufacturer Reason for Recall |
Lack of assurance of sterility, as the sterile barrier may fail.
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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
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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.
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510(K) Database |
510(K)s with Product Code = LQR and Original Applicant = BOSTON SCIENTIFIC CORP.
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