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U.S. Department of Health and Human Services

Class 2 Device Recall Ethylene oxide gas sterilizer

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 Class 2 Recall
Ethylene oxide gas sterilizer
see related information
Date Posted June 30, 2009
Recall Status1 Open
Recall Number Z-1570-2009
Recall Event ID 52124
Premarket Notification
510(K) Number
K981625 
Product Classification Sterilizer, Chemical - Product Code MLR
Product Sterrad 50 Sterilizer, Product Code 10050. Low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Code Information 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.
Recalling Firm/
Manufacturer
Advanced Sterilization Products
33 Technology Drive
Irvine, California 92618
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
DESIGN: Component Design/Selection
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.
Quantity in Commerce 1,151 units.
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MLR and Original Applicant = ADVANCED STERILIZATION PRODUCTS
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