Advanced Sterilization Products

Product Code: 20300 & 20301

2

No

Worldwide Distribution -- United States, Argentina Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, Hungary, Mexico, Panama, Guatemala, Honduras, Poland, Puerto Rico, Virgin Islands, Singapore, Taiwan, Venezuela, Croatia, and Bulgaria.

ASP Automatic Endoscope Reprocessor (AER), Product Code: 20300 & 20301 || The AER is a machine designed to automatically wash and high-level disinfect flexible, submersible fiberoptic or video endoscopes.

Lot Number: 2020

General Hospital and Personal Use Devices

2

No

Worldwide Distribution -- USA, Argentina, Australia, Canada, Chile, Czech Republic, Hong Kong, India, Japan, Panama, Peru and Puerto Rico.

Tyvek Self-Seal Pouch with STERRAD Chemical Indicator 12332. || Intended to be used to contain medical devices that are being terminally sterilized in STERRAD Sterilization Systems.

All Lots.

General Hospital and Personal Use Devices

2

No

Worldwide Distribution.

Sterrad CycleSure Biological Indicator, Product Code 14324. || The Sterrad CycleSure Biological Indicator is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilizer cycles.

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.

General Hospital and Personal Use Devices

2

No

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.

Sterrad 50 Sterilizer, Product Code 10050. || Low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

All serial numbers

General Hospital and Personal Use Devices

2

No

Worldwide Distribution -- USA, Germany, Italy, France, UK, Switzerland, Benelex, Uruguay, Venezuela, Argentina, Chile, Columbia, Ecuador, Belgium, Puerto Rico, Hong Kong, Indonesia, Mexico, Philippines, Austria, China, Greece, Ireland, Israel, Japan, Korea, Malaysia, Singapore, Thailand, Taiwan, Turkey, Middle East, Peru, Canada, Czech Republic, Portugal, South Africa, Spain, Sweden, Hungary, Poland, Brazil, Russia, Egypt, India, and Slovenia.

STERRAD NX Sterilization System Product Code 10033 || The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.