Devices

Stonetome

제조사

Boston Scientific Corporation
  • 제조사 모회사 (2017)
    Boston Scientific
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    SATP

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Device Recall Stonetome
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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.
  • Manufacturer
    Boston Scientific Corp
Device Recall Stonetome
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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.
  • Manufacturer
    Boston Scientific Corp
Device Recall Stonetome
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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.
  • Manufacturer
    Boston Scientific Corp
Device Recall Stonetome
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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.
  • Manufacturer
    Boston Scientific Corp
Device Recall Stonetome
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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.
  • Manufacturer
    Boston Scientific Corp
하나 더 6 건 더