NRAC Issue #1586 ADDENDUM July 12, 2006 NATIONAL RECALL ALERT CENTER - IMMEDIATE WARNING ALERT NOTIFICATION THE FOLLOWING HAVE BEEN RECALLED OR ARE SUBJECT TO FIELD CORRECTION THIS LISTING IS ISSUED BY - NATIONAL RECALL ALERT CENTER, WASHINGTON, D.C. --------------------------------------------------------------------------- PRODUCT a) Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 20 mm cut wire, distal balloon, sterile, single use only, material number M00535110; catalog number 3511. RECALL NUMBER # Z-1109-06; PRODUCT b) Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 30 mm cut wire, distal balloon, sterile, single use only, material number M00535130; catalog number 3513. RECALL NUMBER # Z-1110-06; PRODUCT c) 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. RECALL NUMBER # Z-1111-06; PRODUCT d) Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 20 mm cut wire, proximal balloon, sterile, single use only, material number M00535170; catalog number 3517. RECALL NUMBER # Z-1112-06; PRODUCT e) Boston Scientific Stonetome Stone Removal Device, 5 mm tip, 30 mm cut wire, proximal balloon, sterile, single use only, material number M00535190; catalog number 3519. RECALL NUMBER # Z-1113-6 CODE a) All lots. Lots 588218, 7173503, 7907512, 8541152, 6553517, 7209058, 7923845, 8541153, 6573307, 7213538, 7938899, 6593724, 7238048, 7959199, 6628839, 7244918, 7978741, 6650500, 7312261, 7988003, 6663230, 7323058, 8012669, 6684869, 7345074, 8037031, 6684870, 7368731, 8056507, 6710850, 7394062, 8076206, 6731508, 7416357, 8076207, 6745329, 7441769, 8093643, 6762317, 7469187, 8115498, 6783937, 7487245, 8131913, 6798010, 7510076, 8146780, 6811675, 7536508, 8154851, 6832811, 7550048, 8165619, 6834085, 7570081, 8194623, 6843046, 7592340, 8221047, 6870688, 7613897, 8250992, 6893879, 7635034, 8262323, 6896571, 7635532, 8272381, 6917737, 7656406, 8301236, 6919072, 7701169, 8303922, 6939764, 7722952, 8304044, 6946002, 7738501, 8304054, 6965093, 7738922, 8326168, 6979350, 7773671, 8331426, 6988355, 7794744, 8337750, 7005425, 7813723, 8359941, 7037237, 7833511, 8378721, 7049995, 7833512, 8393169, 7052629, 7845564, 8414769, 7076211, 7845565, 8428051, 7096493, 7864321, 8444985, 7121618, 7891878, 8461221, 7143069, 7892977, 8489777, 7163174, 7900869 and 8509967. b) All lots. Lots 558552, 7739212, 602212, 7753189, 6593723, 7794743, 6632145, 7814338, 6666397, 7836676, 6685227, 7864847, 6713444, 7885211, 6732190, 7938898, 6746552, 7959197, 6787368, 7979136, 6795091, 7997847, 6834079, 8001283, 6846985, 8079834, 6874028, 8119586, 6897533, 8133511, 6900226, 8170294, 6948065, 8203324, 6966289, 8250997, 6987748, 8306742, 6988354, 8306923, 7037239, 8409135, 7052984, 8430041, 7078441, 8459615, 7189065, 8533268, 7213471, 7244925, 7323059, 7351026, 7403584, 7442556, 7485763, 7536756, 7557104, 7656402, 7675613, 7701170 and 7722953. c) 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. d) 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. d) All lots. Lots 224690, 7576902, 6546668, 7701654, 6573600, 7718121, 6603846, 7773069, 6662859, 7803065, 6689054, 7823006, 6706833, 7852755, 6734078, 7865546, 6747479, 7884781, 6763254, 7900823, 6800397, 7918903, 6828545, 7938897, 6874720, 7959841, 6901256, 8012981, 6905390, 8037505, 6930831, 8052326, 6950302, 8114299, 6987742, 8185319, 7037096, 8221046, 7067306, 8251275, 7078440, 8301234, 7121617, 8319260, 7143071, 8360762, 7172640, 8384933, 7215343, 8411896, 7254598, 8415192, 7283355, 8453123, 7309110, 8481169, 7353543, 8533265, 7375265, 7394060, 7418357, 7442997, 7490851, 7544533, 7576853, 7593007 and 7660576. e) All lots. Lots 6604751, 6689295, 6802779, 6848203, 6905391, 7053955, 7098448, 7189064, 7353544, 7442998, 7592642, 7676907, 7703438, 7802899, 7852756, 7938900, 8002453, 8271737 and 8502059. MANUFACTURED & RECALLED BY Boston Scientific Corp., Spencer, IN QUANTITY 47,750 DISTRIBUTION Nationwide and Internationally REASON Lack of assurance of sterility, as the sterile barrier may fail. ---------------------------------------------------------------------------