Events

Recall of Device Recall Ethylene oxide gas sterilizer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Advanced Sterilization Products.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    52124
  • Event Risk Class
    Class 2
  • Event Number
    Z-1570-2009
  • Event Initiated Date
    2009-01-12
  • Event Date Posted
    2009-06-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82152
  • Notes / Alerts
    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.
  • Extra notes in the data
    Sterilizer, chemical - Product Code MLR
  • Reason
    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
  • Model / 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.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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
  • Manufacturer Address
    Advanced Sterilization Products, 33 Technology Drive, Irvine CA 92618
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA