Events

Rappel de Device Recall Ethylene oxide gas sterilizer

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Advanced Sterilization Products.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    52124
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1570-2009
  • Date de mise en oeuvre de l'événement
    2009-01-12
  • Date de publication de l'événement
    2009-06-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-12-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82152
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Sterilizer, chemical - Product Code MLR
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Advanced Sterilization Products, 33 Technology Drive, Irvine CA 92618
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA