ASP Automatic Endoscope Reprocessor, AER Plus Product Code 20300 and AER with printer Product Code 20301 The AER is a machine designed to automatically wash and high-level disinfect flexible, submersible fiberoptic or video endoscopes.
This recall has been terminated (originally issued November 7, 2008).
- Company
- Advanced Sterilization Products
- Recall Initiated
- September 11, 2008
- Posted
- November 7, 2008
- Terminated
- December 27, 2011
- Recall Number
- Z-0281-2009
- Quantity
- 1,578 units installed in the US and 367 units installed internationally
- Firm Location
- Irvine, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Residual high-level disinfectant solution remaining in endoscopes that have been reprocessed in the ASP Automatic Endoscope Reprocessor. If high-level disinfectant, or other fluids, remains in the endoscope after reprocessing, contact with the mucous membranes may occur and result in chemical burns, irritation (chemical colitis), or other symptoms.
Distribution
Worldwide Distribution --- including USA and countries of Italy, UK, Uruguay, Argentina, Chile, Colombia, Ecuador, Puerto Rico, Mexico, Australia, China, Singapore, Taiwan, Middle East, Canada, Czech Republic, Portugal, South Africa, Spain, Hungary, Poland, Brazil, Russia, Egypt, and Slovenia.
Lot / Code Info
Serial Numbers: 19, 42, 75, 104, 123, 131, 155, 239, 283, 312, 333, 391, 396, 427, 437, 4006, 4010, 4017, 4027, 4054, 4059, 4069, 4076, 4093, 4099, 4105, 4110, 4154, 4167, 4172, 4173, 4178, 4180, 4183, 4198, 4206, 4213, 4268, 5037, 7013, 7019, 7044, 7057, 7058, 7061, 7062, 7066, 7073, 7074, 7075, 7077, 7080, 7081, 7083, 7088, 7089, 7094, 7095, 7096, 7102, 7109, 7115, 7121, 7123, 7126, 7127, 7132, 7134, 7136, 7138, 7141, 7143, 7146, 7147, 7148, 7150, 7154, 7159, 7161, 7163, 7164, 7165, 7169, 7170, 7171, 7173, 7175, 7176, 7178, 7179, 7182, 7184, 7185, 7186, 7188, 7189, 7190, 7191, 7192, 7195, 7196, 7198, 7199, 7203, 7208, 7211, 7213, 7214, 7215 7216, 7217, 7218, 7219, 7223, 7224, 7225, 7226, 7228, 7231, 7232, 7234, 7239, 7240, 7242, 7244 7246, 7247, 7249, 7250, 7251, 7252, 7253, 7254, 7255, 7256, 7257, 7258, 7259, 7260, 7261, 7262, 7264, 7265, 7269, 7274, 7275, 7277, 7278, 7279, 7280, 7282, 7287, 7288, 7289, 7290, 7291, 7292, 7295, 7296, 7297, 7298, 7299, 7300, 7301, 7304, 7306, 7307, 7308, 7309, 7310, 7311, 7312, 7318, 7319, 7320, 7321, 7322, 7323, 7324, 7326, 7327, 7328, 7329, 7330, 7331, 7333, 7336, 7338, 7339, 7340, 7341, 7343, 7344, 7346, 7347, 7350, 7351, 7354, 7355, 10007, 10101083146, D060007, D060010, D10001, D110006, D110011, EP110024, EP115001, EP115002, EP115003, EP115004, EP115005, EP115006, EP115007, EP115008, EP115009, EP115011, EP115019, EP115020, EP115022, EP115025, EP115026, EP115032, EP115033, EP115038, EP115040, EP115041, EP115043, EP115044, EP115045, EP115046, EP115048, EP115049, EP115050, EP115051, EP115052, EP115053, EP115054, EP115055, EP115056, EP115057, EP115058, EP115059, EP115060, EP115062, EP115063, EP115064, EP115065, EP115066, EP115067, EP115068, EP115069, EP115070, EP115072, EP115073, EP115074, ep115076, EP115077, EP115078, EP115079, EP115080, EP115081, EP115083, EP115084, EP115085, EP115086, EP115087, EP115088, EP115089, EP115090, EP115091, EP115092, EP115093, EP115094, EP115095, EP115096, EP115097, EP115098, EP115099, EP115100, EP1151001, EP1151002, EP1151003, EP1151005, EP1151006, EP1151007, EP1151008, EP1151009, EP115101, EP1151010, EP1151011, EP1151012, EP1151014, EP1151015, EP1151018, EP1151019, EP115102, EP1151020, EP1151021, EP1151024, EP1151025, EP1151026, EP1151027, EP1151028, EP1151029, EP115103, EP1151030, EP1151031, EP1151032, EP1151033, EP1151034, EP1151035, EP1151037, EP1151038, EP1151039, EP115104, EP1151040, EP1151041, EP1151042, EP1151048, EP1151049, EP1151050, EP1151051, EP1151052, EP1151053, EP1151054, EP1151055, EP1151056, EP1151059, EP1151060, EP1151061, EP1151062, EP1151063, EP1151064, EP1151065, EP115107, EP1151073, EP1151074, EP1151075, EP1151076, EP1151077, EP1151078, EP1151079, EP115108, EP1151080, EP1151081, EP1151082, EP1151084, EP1151085, EP1151086, EP1151087, EP1151089, EP115109, EP1151091, EP1151092, EP1151093, EP1151094, EP1151095, EP1151096, EP1151097, EP1151099, EP1151100, EP1151102, EP1151103, EP1151104, EP1151105, EP1151106, EP1151107, EP1151108, EP1151109, EP115111, EP1151111, EP1151112, EP1151113, EP1151114, EP1151117, EP1151118, EP115112, EP1151120, EP1151121, EP1151122, EP1151124, EP1151127, EP1151128, EP1151129, EP115113, EP1151130, EP1151131, EP1151132, EP1151133, EP1151134, EP1151135, EP1151136, EP1151137, EP1151138, EP1151139, EP115114, EP1151140, EP1151141, EP1151144, EP1151145, EP1151146, EP1151147, EP1151148, EP1151149, EP115115, EP1151150, EP1151151, EP1151152, EP1151153, EP1151154, EP1151155, EP1151156, EP1151157, EP1151158, EP1151159, EP1151160, EP1151161, EP1151162, EP1151163, EP1151164, EP1151165, EP1151167, EP1151169, EP115117. 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EP1151475, EP1151476, EP1151477, EP1151478, EP1151479, EP115148, EP1151480, EP1151481, EP1151482, EP1151483, EP1151484, EP1151485, EP1151486, EP1151487, EP1151488, EP1151489, EP115149, EP1151490, EP1151491, EP1151492, EP1151493, EP1151494, EP1151495, EP1151496, EP1151497, EP1151498, EP1151499, EP115150, EP1151500, EP1151501, EP1151502, EP1151503, EP1151504, EP1151506, EP1151507, EP1151508, EP115151, EP1151510, EP1151511, EP1151512, EP1151513, EP1151514, EP1151515, EP1151516, EP1151517, EP1151518, EP115152, EP1151523, EP1151524, EP1151525, EP1151526, EP1151527, EP1151528, EP1151529, EP115153, EP1151531, EP1151532, EP1151535, EP1151536, EP1151537, EP1151538, EP1151539, EP115154, EP1151540, EP1151545, EP1151546, EP1151547, EP1151549, EP115155, EP1151550, EP1151551, EP1151554, EP1151555, EP1151556, EP1151557, EP1151558, EP1151559, EP115156, EP1151560, EP1151561, EP1151562, EP1151563, EP1151564, EP1151565, EP1151566, EP1151567, EP1151569, EP115157, EP1151570, EP1151571, EP1151572, 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EP115673, EP115674, EP115675, EP115676, EP115678, EP115679, EP115680, EP115681, EP115682, EP115684, EP115685, EP115686, EP115687, EP115688, EP115689, EP115691, EP115692, EP115693, EP115694, EP115695, EP115696, EP115697, EP115698, EP115699, EP115701, EP115703, EP115704, EP115705, EP115706, EP115707, EP115708, EP115709, EP115710, EP115711, EP115712, EP115713, EP115714, EP115715, EP115716, EP115717, EP115718, EP115719, EP115720, EP115721, EP115722, EP115723, EP115724, EP115725, EP115726, EP115727, EP115728, EP115729, EP115732, EP115733, EP115734, EP115735, EP115736, EP115737, EP115738, EP115739, EP115740, EP115741, EP115742, EP115743, EP115744, EP115745, EP115746, EP115747, EP115748, EP115749, EP115750, EP115752, EP115753, EP115754, EP115755, EP115756, EP115761, EP115762, EP115763, EP115764, EP115765, EP115766, EP115767, EP115768, EP115769, EP115771, EP115772, EP115775, EP115776, EP115777, EP115778, EP115779, EP115780, EP115781, EP115783, EP115784, EP115785, EP115786, EP115787, EP115788, EP115789, EP115790, EP115791, EP115792, EP115793, EP115794, EP115795, EP115796, EP115797, EP115798, EP115799, EP115800, EP115802, EP115804, EP115805, EP115806, EP115807, EP115810, EP115811, EP115812, EP115813, EP115815, EP115816, EP115817, EP115818, EP115819, EP115820, EP115821, EP115822, EP115824, EP115825, EP115826, EP115827, EP115828, EP115829, EP115830, EP115831, EP115832, EP115833, EP115834, EP115835, EP115836, EP115837, EP115838, EP115839, EP115840, EP115841, EP115842, EP115843, EP115844, EP115845, EP115846, EP115847, EP115848, EP115849, EP115850, EP115851, EP115855, EP115856, EP115857, EP115858, EP115859, EP115860, EP115861, EP115862, EP115864, EP115865, EP115866, EP115867, EP115869, EP115870, EP115871, EP115872, EP115873, EP115874, EP115875, EP115876, EP115877, EP115878, EP115880, EP115881, EP115882, EP115883, EP115884, EP115885, EP115886, EP115887, EP115888, EP115889, EP115890, EP115891, EP115892, EP115893, EP115894, EP115895, EP115896, EP115897, EP115898, EP115899, EP115900, EP115901, EP115902, EP115903, EP115904, EP115905, EP115906, EP115907, EP115908, EP115909, EP115912, EP115913, EP115914, EP115915, EP115916, EP115917, EP115919, EP115920, EP115921, EP115923, EP115924, EP115925, EP115927, EP115928, EP115929, EP115930, EP115931, EP115932, EP115934, EP115935, EP115936, EP115937, EP115938, EP115939, EP115940, EP115941, EP115942, EP115943, EP115944, EP115945, EP115947, EP115948, EP115949, EP115950, EP115951, EP115952, EP115954, EP115955, EP115956, EP115957, EP115958, EP115959, EP115960, EP115961, EP115962, EP115963, EP115964, EP115965, EP115967, EP115968, EP115969, EP115970, EP115971, EP115972, EP115973, EP115974, EP115975, EP115976, EP115977, EP115978, EP115979, EP115980, EP115981, EP115982, EP115983, EP115984, EP115985, EP115986, EP115987, EP115988, EP115989, EP115990, EP115991, EP115992, EP115993, EP115994, EP115995, EP115996, EP115997, EP115998, EP115999, ep116000, EP151036, and EP151049.
Root Cause
Component design/selection
Action Taken
ASP is mailing customer notification CL-101367 and AD-52976-001 in an Urgent Product Correction envelope starting the week of September 8, 2008. The letter advises that the firm has received customer reports of residual high-level disinfectant solution remaining in endoscopes that have been reprocessed in the ASP Automatic Endoscope Reprocessor (AER). If high-level disinfectant, or other fluids, remain in the endoscope after reprocessing, contact with patient mucous membranes may occur and result in chemical burns, irritation (chemical colitis), or other symptoms. ASP has tested the PENTAX 70 series endoscopes containing FWJ (Forward Water Jet) and has confirmed that residual fluids may remain in the PENTAX 70 series endoscopes with a FWJ after reprocessing. To eliminate any residual fluids, ASP is recommending customers follow the revised instructions when reprocessing PENTAX 70 series endoscopes with a FWJ. A copy of the revised instructions is provided with the notification letter.