510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-1111-06

Boston Scientific Stonetome Stone Removal Device, 5 mm tip, 20 mm cut wire, proximal balloon, sterile, single...

Boston Scientific Corporation / initiated 2006-05-19 / Terminated / root cause: packaging
FDA source (opens on fda.gov)

Boston Scientific Corp began a recall of Boston Scientific Stonetome Stone Removal Device, 5 mm tip, 20 mm cut wire, proximal balloon, sterile, single use only, material number M00535150; catalog... on . The reason FDA records is "Lack of assurance of sterility, as the sterile barrier may fail". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-1111-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Boston Scientific Corporation
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.
Product code
LQR Dislodger, Stone, Biliary
Reason for recall
Lack of assurance of sterility, as the sterile barrier may fail.
Root cause tag
packaging
FDA root cause
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.
Product codes and lots
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.