Events

Retiro De Equipo (Recall) de Device Recall Ethylene oxide gas sterilizer

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Advanced Sterilization Products.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    52124
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1570-2009
  • Fecha de inicio del evento
    2009-01-12
  • Fecha de publicación del evento
    2009-06-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82152
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Sterilizer, chemical - Product Code MLR
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    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.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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
  • Dirección del fabricante
    Advanced Sterilization Products, 33 Technology Drive, Irvine CA 92618
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA