Events

Device Recall Ethylene oxide gas sterilizer 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Advanced Sterilization Products 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
    52124
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1570-2009
  • 사례 시작날짜
    2009-01-12
  • 사례 출판 날짜
    2009-06-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-12-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82152
  • 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
    Sterilizer, chemical - Product Code MLR
  • 원인
    The capacitor in the vacuum pump component within the sterrad 50 system could overheat and potentially create a hazardous condition inside the system, resulting in smoke and/or fire.
  • 조치
    Advanced Sterilization Products (ASP) sent an "Urgent: Product Correction" letter dated January 12, 2009 to each consignee informing them of the issue and instructed them to report smoke or a burning odors in or around their STERRAD 50 System. ASP strongly recommended for consignees to follow their facility's safety protocols and if possible, immediately disconnect the STERRAD 50 System from its electrical source. Customers were instructed to contact ASP to schedule an onsite visit to investigate the issue. If the issue is caused by a malfunctioning capacitor in the vacuum pump, the firm will replace the malfunctioning component right away. To correct this situation, an ASP Field Service Engineer (FSE) will visit all customers facilities within the next sixty days to replace the capacitor in the vacuum pump on the affected STERRAD 50 System.

Device

Device Recall Ethylene oxide gas sterilizer
  • 모델명 / 제조번호(시리얼번호)
    Affected units in the US: 10050000502, 10050000505, 10050000509, 10050000510 10050000513, 10050000516, 10050000517, 10050000532, 10050000534, 10050000545, 10050000548, 10050000549, 10050000551, 10050000552, 10050000554, 10050000564, 10050000567, 10050000570, 10050000574, 10050000576, 10050000588, 10050000597, 10050000606, 10050000609, 10050000613, 10050000614, 10050000615, 10050000616, 10050000617, 10050000618, 10050000621, 10050000624, 10050000625, 10050000627, 10050000635, 10050000644, 10050000648, 10050000653, 10050000662, 10050000673, 10050000676, 10050000680, 10050000686, 10050000692, 10050000694, 10050000705, 10050000710, 10050000712, 10050000713, 10050000714, 10050000717, 10050000725, 10050000727, 10050000728, 10050000729, 10050000730, 10050000739, 10050000745, 10050000756, 10050000759, 10050000760, 10050000762, 10050000767, 10050000768, 10050000773, 10050000774, 10050000779, 10050000782, 10050000784, 10050000800, 10050000801, 10050000803, 10050000804, 10050000806, 10050000813, 10050000815, 10050000822, 10050000832, 10050000834, 10050000835, 10050000837, 10050000840, 10050000844, 10050000849, 10050000850, 10050000852, 10050000855, 10050000857, 10050000858, 10050000863, 10050000864, 10050000866, 10050000867, 10050000868, 10050000869, 10050000872, 10050000873, 10050000874, 10050000877, 10050000895, 10050000897, 10050010911, 10050010916, 10050010918, 10050010922, 10050010941, 10050010945, 10050010948, 10050010952, 10050021012, 10050021013, 10050021016, 10050021022, 10050021029, 10050021030, 10050021031, 10050021032, 10050021033, 10050021034, 10050021036, 10050021037, 10050021038, 10050021041, 10050021042, 10050021043, 10050021045, 10050021046, 10050021049, 10050021050, 10050021054, 10050021059, 10050021060, 10050021064, 10050021069, 10050021087, 10050021092, 10050021094, 10050021095, 10050021097, 10050021099, 10050021100, 10050021103, 10050021104, 10050021106, 10050021110, 10050021111, 10050021112, 10050021116, 10050021136, 10050021137, 10050021139, 10050021140, 10050021142, 10050021145, 10050021146, 10050021147, 10050021148, 10050021149, 10050021150, 10050035004, 10050035006, 10050035008, 10050035011, 10050035013, 10050035014, 10050035015, 10050035022, 10050035023, 10050035027, 10050035028, 10050035030, 10050035034, 10050035035, 10050035036, 10050035037, 10050035039, 10050035041, 10050035042, 10050035044, 10050035046, 10050035050, 10050035051, 10050035054, 10050035055, 10050035059, 10050035060, 10050035061, 10050035063, 10050035065, 10050035066, 10050035067, 10050035070, 10050035071, 10050035074, 10050035075, 10050035076, 10050035077, 10050035078, 10050035086, 10050035094, 10050035100, 10050035101, 10050035103, 10050035104, 10050035105, 10050035106, 10050035111, 10050035116, 10050035117, 10050035118, 10050035119, 10050035121, 10050035124, 10050035126, 10050035127, 10050035128, 10050035129, 10050035130, 10050035131, 10050035132, 10050035134, 10050035135, 10050035136, 10050035137, 10050035139, 10050035140, 10050035141, 10050035142, 10050035143, 10050035144, 10050035148, 10050035149, 10050035153, 10050035154, 10050035155, 10050035156, 10050035157, 10050035158, 10050035160, 10050035162, 10050035164, 10050035166, 10050035167, 10050035170, 10050035171, 10050035172, 10050035173, 10050035174, 10050035175, 10050035179, 10050035181, 10050035182, 10050035184, 10050035185, 10050035188, 10050035196, 10050035204, 10050035205, 10050035321, 10050035323, 10050035324, 10050035385, 10050970298, 10050970344, 10050980382, 10050980383, 10050980478, 10050980356, 10050980408, 10050980434, 10050980450, 10050980452, 10050980464, 10050970312 and 10050000500 and   Affected units distributed internationally :  10050021141, 10050035146, 10050960065, 10050970149, 10050970201, 10050970253, 10050980089,  10050021143, 10050035161, 10050960066, 10050970150, 10050970202, 10050970254, 10050980345,  10050021144, 10050035163, 10050960067, 10050970151, 10050970203, 10050970255, 10050980346,  10050027061, 10050035165, 10050960068, 10050970152, 10050970204, 10050970256, 10050980347,  10050035001, 10050035168, 10050960069, 10050970153, 10050970205, 10050970257, 10050980348,  10050035003, 10050035176, 10050960070, 10050970154, 10050970206, 10050970258, 10050980351,  10050035005, 10050035177, 10050960071, 10050970155, 10050970207, 10050970259, 10050980353,  10050035007, 10050035178, 10050960072, 10050970156, 10050970208, 10050970260, 10050980354,  10050035009, 10050035180, 10050960073, 10050970157, 10050970209, 10050970261, 10050980357,  10050035010, 10050035183, 10050960075, 10050970158, 10050970210, 10050970262, 10050980358,  10050035016, 10050035186, 10050960076, 10050970159, 10050970211, 10050970263, 10050980363,  10050035017, 10050035187, 10050960078, 10050970160, 10050970212, 10050970264, 10050980381,  10050035018, 10050035189, 10050960080, 10050970161, 10050970213, 10050970265, 10050980384,  10050035019, 10050035190, 10050960083, 10050970162, 10050970214, 10050970269, 10050980385,  10050035020, 10050035191, 10050960086, 10050970163, 10050970215, 10050970270, 10050980391,  10050035021, 10050035192, 10050960087, 10050970164, 10050970216, 10050970271, 10050980393,  10050035024, 10050035193, 10050960088, 10050970165, 10050970217, 10050970272, 10050980396,  10050035026, 10050035194, 10050960092, 10050970166, 10050970218, 10050970273, 10050980398,  10050035031, 10050035195, 10050960096, 10050970167, 10050970219, 10050970276, 10050980399,  10050035038, 10050035197, 10050960098, 10050970168, 10050970220, 10050970277, 10050980400,  10050035040, 10050035198, 10050960099, 10050970169, 10050970221, 10050970278, 10050980402,  10050035043, 10050035199, 10050960101, 10050970170, 10050970222, 10050970279, 10050980403,  10050035045, 10050035200, 10050960103, 10050970171, 10050970223, 10050970280, 10050980405,  10050035047, 10050035202, 10050960104, 10050970172, 10050970224, 10050970283, 10050980413,  10050035048, 10050035203, 10050960105, 10050970173, 10050970225, 10050970287, 10050980414,  10050035052, 10050035206, 10050960106, 10050970174, 10050970226, 10050970288, 10050980415,  10050035056, 10050035349, 10050960111, 10050970176, 10050970227, 10050970289, 10050980417,  10050035057, 10050035357, 10050960117, 10050970177, 10050970228, 10050970290, 10050980424,  10050035058, 10050038295, 10050960118, 10050970178, 10050970229, 10050970292, 10050980425,  10050035072, 10050096063, 10050960119, 10050970179, 10050970230, 10050970293, 10050980426,  10050035073, 10050098041, 10050960314, 10050970180, 10050970232, 10050970300, 10050980427,  10050035080, 10050960028, 10050960322, 10050970181, 10050970233, 10050970301, 10050980436,  10050035081, 10050960030, 10050970120, 10050970182, 10050970234, 10050970302, 10050980437,  10050035082, 10050960036, 10050970121, 10050970183, 10050970235, 10050970306, 10050980438,  10050035083, 10050960041, 10050970123, 10050970184, 10050970236, 10050970311, 10050980439,  10050035085, 10050960046, 10050970124, 10050970185, 10050970237, 10050970313, 10050980441,  10050035088, 10050960050, 10050970128, 10050970186, 10050970238, 10050970321, 10050980442,  10050035090, 10050960051, 10050970130, 10050970187, 10050970239, 10050970323, 10050980443,  10050035095, 10050960052, 10050970131, 10050970188, 10050970240, 10050970324, 10050980444,  10050035096, 10050960053, 10050970134, 10050970189, 10050970241, 10050970325, 10050980446,  10050035097, 10050960054, 10050970136, 10050970190, 10050970242, 10050970326, 10050980447,  10050035098, 10050960055, 10050970138, 10050970191, 10050970243, 10050970327, 10050980448,  10050035099, 10050960056, 10050970140, 10050970192, 10050970244, 10050970329, 10050980449,  10050035102, 10050960057, 10050970141, 10050970193, 10050970245, 10050970329, 10050980453,  10050035108, 10050960058, 10050970142, 10050970194, 10050970246, 10050970330, 10050980461,  10050035112, 10050960059, 10050970143, 10050970195, 10050970247, 10050970331, 10050980462,  10050035113, 10050960060, 10050970144, 10050970196, 10050970248, 10050970332, 10050980469,  10050035114, 10050960061, 10050970145, 10050970197, 10050970249, 10050970333, 10050980470,  10050035122, 10050960062, 10050970146, 10050970198, 10050970250, 10050970338, 10050980471,  10050035125, 10050960063, 10050970147, 10050970199, 10050970251, 10050970339, 10050980475,  10050035145, 10050960064, 10050970148, 10050970200, 10050970252, 10050970340 and 10050980480.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, Germany, Italy, France, United Kingdom, Switzerland, Benelex, Uruguay, Venezuela, Argentina, Chile, Columbia, Belgium, Puerto Rico, Mexico, Philipines, Australia, Japan, Korea, Malaysia, Taiwan, Middle East, Peru, Canada, Czech Republic, Portugal, Spain, Sweden, Hungary, Poland, Brazil, Russia, Finland, Norway, Panama and Switzerland.
  • 제품 설명
    Sterrad 50 Sterilizer, Product Code 10050. || Low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

Advanced Sterilization Products
  • 제조사 주소
    Advanced Sterilization Products, 33 Technology Drive, Irvine CA 92618
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA