Events

Device Recall Ambulatory Infusion Pump 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Zevex International, Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    57939
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1869-2011
  • 사례 시작날짜
    2011-02-28
  • 사례 출판 날짜
    2011-04-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97788
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Pump, infusion - Product Code FRN
  • 원인
    Infusion pumps may exhibit false error codes which render the device inoperable until a recovery process is performed.
  • 조치
    The firm, MOOG, sent an "URGENT DEVICE RECALL NOTIFICATION" letter dated February 28, 2011 to its customers. The letter described the product, problem and actions to be taken. The Customers were instructed to do the following: 1) Identify the affected Pumps: a) If they have an affected pump, fill out and return the enclosed Business Reply Card within five (5) working days. b) If their pump is not affected by this recall, the pump can be used for its intended purposes. 2) Removal of affected Product: a) remove affected products from service and use non-affected pump b) If you do not have an alternate pump available for use, MOOG recommended that they weigh the risks and benefits for delivering medications using the affected pump versus the risk of not using any pump for each patient WARNING: Affected pumps should not be used to deliver critical medications where a delay in therapy could result in serious adverse health effects, injury or death; and affected pumps should not be used with the neonatal population. 3)Should they Have an Affected pump which exhibits Error Code 45 or is used in therapeutic situations specified in the warning, please contact MOOG Customer Service at (800) 970-2337, Monday thru Friday, 7:00am to 5:00pm MST to arrange for a loaner pump and the return of your affected pump. If you have any additional questions regarding this recall, please contact MOOG's Customers Service Department at (800) 970-2337.

Device

Device Recall Ambulatory Infusion Pump
  • 모델명 / 제조번호(시리얼번호)
    200078, 200080, 200081, 200086, 200086, 200090, 200092, 200097, 200103 200109, 200110, 200116, 200118, 200118, 200119, 200124, 200125, 200129 200135, 200136, 200137, 200137, 200143, 200143, 200144, 200144, 200147 200153, 200154, 200155, 200157, 200159, 200164, 200164, 200166, 200167, 200184, 200185, 200186, 200187, 200272, 200409, 200456, 200488, 200492, 200504, 200505, 200506, 200511, 200516, 200517, 200518, 200519, 200521, 200523, 200524, 200525, 200540, 200541, 200543, 200546, 200548, 200550, 200553, 200556, 200569, 200570, 200571,200581, 200593, 200601, 200605, 200633, 200634, 200635, 200636, 200641, 200644, 200645, 200646, 200647, 200649, 200650, 200651, 200652, 200653, 200654, 200655, 200656, 200657, 200659, 200660, 200662, 200663, 200664, 200665, 200666, 200667, 200668, 200670, 200673, 200674, 200675, 200677, 200678, 200679, 200680, 200681, 200683, 200684, 200685, 200686, 200687, 200688, 200689, 200690, 200691, 200693, 200694, 200695, 200696, 200697, 200698, 200699, 200700, 200701, 200703, 200704, 200705, 200706, 200707, 200708, 200709, 200710, 200711, 200714, 200715, 200716, 200717, 200718, 200719, 200720, 200721, 200722, 200724, 200726, 200727, 200728, 200729, 200730, 200731, 200732, 200733, 200735, 200736, 200737, 200738, 200739, 200740, 200741, 200742, 200743, 200745, 200746, 200748, 200749, 200750, 200751, 200752, 200753, 200754, 200756, 200757, 200758, 200759, 200760, 200761, 200762, 200763, 200765, 200768, 200770, 200771, 200772, 200773, 200775, 200776, 200777, 200778, 200780, 200781, 200782, 200783, 200784, 200785, 200786, 200787, 200789, 200791, 200793, 200794, 200795, 200796, 200797, 200798, 200799, 200800, 200803, 200804, 200805, 200806, 200807, 200808, 200809, 200810, 200811, 200813, 200814, 200815, 200816, 200817, 200818, 200819, 200820, 200821, 200823, 200824, 200825, 200826, 200827, 200828, 200829, 200830, 200831, 200833, 200835, 200836, 200837, 200839, 200840, 200841, 200842, 200843, 200846, 200847, 200848, 200849, 200850, 200851, 200853, 200854, 200855, 200858, 200859, 200860, 200861, 200862, 200863, 200864, 200865, 200866, 200868, 200869, 200870, 200872, 200873, 200874, 200875, 200876, 200877, 200880, 200882, 200883, 200884, 200885, 200886, 200887, 200888, 200889, 200891, 200892, 200893, 200894, 200895, 200896, 200897, 200899, 200900, 200902, 200903, 200904, 200905, 200906, 200907, 200908, 200909, 200910, 200912, 200913, 200914, 200915, 200916, 200917, 200918, 200919, 200920, 200923, 200924, 200925, 200926, 200927, 200928, 200929, 200930, 200931, 200933, 200934, 200935, 200937, 200938, 200939, 200941, 200942, 200946, 200955, 200971, 200975, 200993, 200996, 200998, 201000, 201002, 201006, 201010, 201012, 201014, 201015, 201016, 201018, 201024, 201034, 201038, 201041, 201045, 201046, 201054, 201055, 201056, 201063, 201064, 201065, 201067, 201068, 201075, 201076, 201079, 201080, 201165, 201245, 201284, 201295, 201296, 201299, 201324, 201345, 201347, 201356, 201357, 201358, 201361, 201363, 201364, 201365, 201366, 201367, 201368, 201370, 201371, 201379, 201407, 201409, 201411, 201414, 201417, 201427, 201428, 201429, 201431, 201432, 201433, 201434, 201435, 201436, 201437, 201438, 201439, 201441, 201442, 201459, 201460, 201461, 201463, 201465, 201467, 201470, 201548, 201674, 201678, 201679, 201681, 201683, 201685, 201694, 201700, 201713, 201714, 201715, 201716, 201718, 201719, 201720, 201724, 201725, 201732, 201734, 201736, 201737, 201739, 201740, 201741, 201745, 201759, 201770, 201771, 201773, 201776, 201778, 201779, 201780, 201781, 201782, 201789, 201791, 201793, 201794, 201795, 201800, 201804, 201810, 201812, 201814, 201816, 201817, 201830, 201830, 201830, 201860, 201861, 201862, 201864, 201866, 201868, 201879, 201880, 201882, 201884, 201912, 201918, 201952, 201996, 202010, 202033, 202035, 202038, 202040, 202042, 202043, 202053, 202062, 202063, 202065, 202066, 202067, 202068, 202069, 202076, 202078, 202079, 202081, 202082, 202083, 202084, 202085, 202086, 202087, 202091, 202098, 202100, 202101, 202102, 202103, 202104, 202106, 202107, 202109, 202111, 202112, 202113, 202114, 202115, 202116, 202117, 202118, 202125, 202126, 202127, 202128, 202129, 202130, 202131, 202132, 202157, 202159, 202161, 202162, 202170, 202171, 202172, 202173, 202174, 202175, 202196, 202197, 202198, 202199, 202200, 202201, 202202, 202203, 202204, 202208, 202209, 202212, 202213, 202214, 202215, 202216, 202218, 202220, 202232, 202233, 202234, 202236, 202237, 202238, 202239, 202243, 202244, 202273, 202274, 202279, 202281, 202284, 202285, 202294, 202305, 202323, 202332, 202334, 202335, 202336, 202337, 202338, 202340, 202341, 202342, 202345, 202346, 202347, 202348, 202349, 202350, 202351, 202352, 202355, 202358, 202361, 202362, 202382, 202395, 202404, 202419, 202542, 202552, 202757, 202774, 202783, 202801, 202807, 202808, 202810, 202811, 202813, 202815, 202816, 202817, 202819, 202823, 202841, 202842, 202843, 202845, 202847, 202848, 202849, 202894, 202918, 202919, 202951, 202987, 202988, 202990, 202991, 202992, 202996, 202997, 203198, 203413, 203414, 203415, 203417, 203418, 203835, 203900, 203924, 203936, 203939, 203953, 203976, 204025, 204026, 204027, 204253, 205531, 205583, 205995, 206053, 206216, 206462, 206688, 206724, 206726, 206732, 206745, 206747, 206836, 206841, 206863, 206864, 206865, 206866, 207186, 207413, 207430, 207512, 207513, 207587, 207628, 207695, 207695, 207762, 207778, 207807, 207807, 207810, 208003, 208049, 208060, 208183, 208198, 208298, 210022, 210025, 210026, 210028, 210029, 210030, 210031, 210073, 210075, 210076, 210077, 210078, 210096, 210137, 210138, 210140, 210142, 210143, 210144, 210150, 210204, 210232, 210262, 210263, 210291, 210292, 210350, 210356, 210358, 210360, 210444, 210445, 210448, 210452, 210452, 210458, 210477, 210512, 210514, 210536, 210537, 210538, 210539, 210540, 210540, 210541, 210545, 210550, 210553, 210554, 210584, 210626, 210630, 210631, 210632, 210633, 210651, 210667, 210680, 210682, 210684, 210686, 210943, 210946, 210947, 210948, 210993, 211102, 211103, 211218, 211245, 211293, 211294, 211295, 211296, 211298, 211300, 211301, 211302, 211304, 211337, 211457, 211528, 211529, 211531, 211532, 211533, 211534, 211535, 211536, 211537, 211538, 211539, 211541, 211542, 211543, 211544, 211546, 211547, 211548, 211549, 211550, 211552, 211553, 211554, 211555, 211556, 211638, 211640, 211644, 212479, 212505, 212506, 212527, 212533, 212540, 212558, 212560, 212562, 212563, 212565, 212568, 212572, 212573, 212576, 212578, 212581, 212666, 212671, 212686, 212688, 212689, 212690, 212691, 212692, 212696, 212697, 212698, 212701, 212715, 212716, 212752, 212755, 212756, 212760, 213901, 203198.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA and countries including: Australia, Canada, Costa Rica, Croatia, Dubai, France, Germany, Ireland, Italy, Japan, Jordan, Kuwait, Malaysia, New Zealand, Qatar, Saudi Arabia, Singapore, South Africa, Taiwan, Turkey, UAE, United Kingdom.
  • 제품 설명
    Curlin PainSmart Ambulatory Infusion Pump || Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.
  • Manufacturer
    Zevex International, Inc.

Manufacturer

Zevex International, Inc.
  • 제조사 주소
    Zevex International, Inc., 4314 Zevex Park Ln, Salt Lake City UT 84123
  • 제조사 모회사 (2017)
    Moog Inc
  • Source
    USFDA