| | Class 2 Recall
Ethylene oxide gas sterilizer |  |
| Date Posted |
June 30, 2009 |
| Recall Number |
Z-1570-2009 |
| 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 |
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.
|
| 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. |
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