|
Class 2 Device Recall ASP Automatic Endoscope Reprocessor |
|
Date Initiated by Firm |
September 11, 2008 |
Date Posted |
November 07, 2008 |
Recall Status1 |
Terminated 3 on December 27, 2011 |
Recall Number |
Z-0281-2009 |
Recall Event ID |
49451 |
510(K)Number |
K832458
|
Product Classification |
Cleaning Accessories for Endoscope - Product Code FEB
|
Product |
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. |
Code Information |
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.
EP1151170, EP1151171, EP1151172, ep1151173, ep1151174, ep1151175, ep1151176, ep1151177, ep1151178, ep1151179, EP115118, ep1151180, ep1151181, ep1151182, ep1151183, ep1151184, ep1151185, ep1151186, ep1151187, ep1151188, ep1151189, ep1151190, ep1151191, ep1151192, ep1151193, ep1151194, EP1151195, ep1151196, ep1151197, ep1151198, ep1151200, EP1151201, ep1151202, EP1151203, EP1151204, EP1151205, EP1151206, EP1151207, EP1151208, EP1151209, EP115121, EP1151210, EP1151211, EP1151212, EP1151213, EP1151214, EP1151215, EP1151216, EP1151217, EP1151218, EP1151219, EP115122, EP1151220, EP1151221, EP1151222, EP1151223, EP1151224, EP1151225, EP1151226,, EP1151227, EP1151228, EP1151229, EP115123, EP1151230, EP1151231, EP1151232, EP1151233, EP1151234, EP1151235, EP1151236, EP1151237, EP1151238, EP1151239, EP115124, EP1151240, EP1151241, EP1151243, EP1151244, EP1151245, EP1151246, EP1151248, Ep1151250, EP1151251, EP1151252, EP1151253, EP1151254, EP1151255, EP1151256, EP1151257, EP1151258, EP1151260, EP1151261, EP1151262, EP1151263, EP1151264, EP1151265, EP1151266, EP1151268, EP1151269, EP115127, EP1151270, EP1151271, EP1151273, EP1151274, EP1151275, EP1151276, EP1151277, EP1151278, EP1151279, EP1151280, EP1151281, EP1151282, EP1151283, EP1151284, EP1151285, EP1151286, EP1151287, EP1151288, EP1151289, EP115129, EP1151290, EP1151291 EP1151292, EP1151293, EP1151295, EP1151296, EP1151297, EP1151298, EP1151299, EP115130, EP1151300, EP1151301, EP1151302, EP1151303, EP1151304, EP1151305, EP1151306, EP1151307, EP1151308, EP1151309, EP115131, EP1151310, EP1151311, EP1151312, EP1151313, EP1151314, EP1151315, EP1151316, EP1151318, EP1151319, EP115132, EP1151320, EP1151321, EP1151322, EP1151323, EP1151324, EP1151325, EP1151329, EP115133, EP1151330, EP1151333, EP1151334, ep1151335, EP1151336, EP1151337, EP1151338, EP1151339, EP115134, EP1151340, EP1151341, EP1151343, EP1151344, EP1151345, EP1151348, EP1151349, EP115135, EP1151350, EP1151351, EP1151352, EP1151353, EP1151354, EP1151355, EP1151356, EP1151357, EP1151359, EP115136, EP1151360, EP1151361, EP1151362, EP1151367, EP115137, EP1151370, EP1151371, EP1151372, EP1151373, EP1151374, EP1151375, EP1151376, EP1151377, EP1151379, EP115138, EP1151380, EP1151381, EP1151382, EP1151383, EP1151384, EP1151385, EP1151387, EP115139, EP1151392, EP1151393, EP1151394, EP1151395, EP1151398, EP1151399, EP1151402, EP1151403, EP1151404, EP1151405, EP1151406, EP1151407, EP1151408, EP1151409, EP1151410, EP1151411, Ep1151412, EP1151414, EP1151415 EP1151416, EP1151417, EP1151418, EP1151419, EP1151420, EP1151421, EP1151422, EP1151423, EP1151424, EP1151426, EP1151427, EP1151428, EP1151429, EP1151430, EP1151431, EP1151432, EP1151434, EP1151435, EP1151436, EP1151439, EP1151440, EP1151441, EP1151442, EP1151443, EP1151448, EP1151449, EP1151450, EP1151451, EP1151452, EP1151455, EP1151457, EP1151458, EP115146, EP1151460, EP1151461, EP1151462, EP1151463, EP1151464, EP1151465, EP1151466, EP1151467, EP1151468, EP1151469, EP115147, EP1151473, 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, EP1151573, EP1151574, EP1151575, EP1151577, EP115158, EP115159, EP1151590, EP1151591, EP1151593, EP1151594, EP1151595, EP1151596, EP1151597, EP1151598, EP1151599, EP115160, EP1151600, EP1151601, EP1151602, EP1151603, EP1151605, EP1151606, EP1151608, EP1151610, EP1151611, EP1151612, EP1151613, EP1151615, EP1151618, EP1151619, EP115162, EP1151621, EP1151622, EP1151623, EP1151624, EP1151625, EP1151626, EP1151627, EP1151629, EP115163, EP1151634, EP1151635, EP115164, EP115166, EP1151667, EP115167, EP115168, EP115169, EP115171, EP115172, EP115173, EP115174, EP115175, EP115176, EP115177, EP115178, EP115179, EP115180, EP115181, EP115182, EP115184, EP115185, EP115186, EP115187, EP115188, EP115189, EP115191, EP115192, EP115193, EP115194, EP115195, EP115200, EP115201, EP115202, EP115203, EP115204, EP115205, EP115206, EP115207, EP115208, EP115209, EP115210, EP115212, EP115213, EP115214, EP115215, EP115216, EP115217, EP115218, EP115219, EP115221, EP115222, EP115223, EP115224, EP115227, EP115228, EP115229, EP115230, EP115231, EP115232, EP115233, EP115234, EP115235, EP115236, EP115237, EP115238, EP115239, EP115240, EP115241, EP115242, EP115243, EP115244, EP115245, EP115246, EP115247, EP115248, EP115249, EP115250, EP115251, EP115252, EP115253, EP115254, EP115255, EP115256, EP115258, EP115259, EP115260, EP115261, EP115262, EP115263, EP115264, EP115265, EP115266, EP115267, EP115268, EP115269, EP115270, EP115271, EP115272, EP115273, EP115274, EP115275, EP115276, EP115277, EP115278, EP115279, EP115280, EP115281, EP115282, EP115284, EP115285, EP115286, EP115287, EP115288, EP115289, EP115290, EP115291, EP115292, EP115293, EP115294, EP115295, EP115296, EP115297, EP115298, EP115299, EP115300, EP115301, EP115302, EP115303, EP115304, EP115305, EP115306, EP115307, EP115308, EP115309, EP115310, EP115311, EP115312, EP115313, EP115314, EP115315, EP115316, EP115317, EP115318, EP115319, EP115320, EP115323, EP115324, EP115326, EP115327, EP115328, EP115329, EP115330, EP115331, EP115332, EP115333, EP115334, EP115335, EP115336, EP115337, EP115338, EP115339, EP115340, EP115343, EP115344, EP115345, EP115346, EP115347, EP115348, EP115349, EP115350, EP115352, EP115353, EP115354, EP115355, EP115356, EP115357, EP115358, EP115359, EP115360, EP115361, EP115364, EP115365, EP115366, EP115367, EP115369, EP115371, EP115374, EP115375, EP115376, EP115377, EP115378, EP115379, EP115380, EP115381, EP115383, EP115384, EP115385, EP115386, EP115387, EP115388, EP115389, EP115390, EP115392, EP115393, EP115394, EP115395, EP115396, EP115397, EP115400, EP115401, EP115402, EP115403, EP115404, EP115405, EP115406, EP115407, EP115408, EP115409, EP115410, EP115412, EP115413, EP115414, EP115415, EP115416, EP115417, EP115418, EP115419, EP115420, EP115421, EP115422, EP115423, EP115424, EP115425, EP115426, EP115427, EP115428, EP115429, EP115430, EP115431, EP115432, EP115433, EP115434, EP115435, EP115436, EP115437, EP115438, EP115439, EP115441, EP115442, EP115443, EP115444, EP115446, EP115448, EP115449, EP115450, EP115451, EP115452, EP115453, EP115454, EP115455, EP115456, EP115457, EP115458, EP115459, EP115460, EP115461, EP115462, EP115463, EP115464, EP115465, EP115466, EP115467, EP115468, EP115469, EP115471, EP115472, EP115473, EP115474, EP115475, EP115476, EP115477, EP115478, EP115479, EP115480, EP115481, EP115482, EP115483, EP115484, EP115485, EP115486, EP115487, EP115488, EP115489, ep115490, EP115491, EP115492, EP115493, EP115494, EP115495, EP115496, EP115498, EP115499, EP115500, EP115501, EP115502, EP115503, EP115504, EP115506, EP115507, EP115508, EP115509, EP115510, EP115511, EP115512, EP115513, EP115514, EP115515, EP115516, EP115517, EP115518, EP115519, EP115520, EP115521, EP115522, ep115523, EP115524, ep115525, EP115526, EP115527, EP115528, EP115529, EP115530, EP115531, EP115532, EP115533, EP115534, EP115535, EP115536, EP115537, EP115539, EP115540, EP115542, EP115543, EP115544, EP115545, EP115546, EP115547, EP115548, EP115549, EP115550, EP115551, EP115552, EP115553, EP115554, EP115555, EP115556, EP115557, EP115558, EP115559, EP115560, EP115561, EP115562, EP115563, EP115564, EP115565, EP115566, EP115567, EP115568, EP115570, EP115571, EP115572, EP115573, EP115574, EP115575, EP115576, EP115577, EP115578, EP115584, EP115586, EP115587, EP115591, EP115592, EP115593, EP115594, EP115600, EP115601, EP115602, EP115603, EP115604, EP115605, EP115606, EP115607, EP115608, EP115609, EP115610, EP115611, EP115612, EP115613, EP115614, EP115615, EP115616, EP115617, EP115618, EP115619, EP115620, EP115621, EP115622, EP115623, EP115624, EP115625, EP115626, EP115627, EP115628, EP115629, EP115630, EP115631, EP115632, EP115633, EP115634, EP115636, EP115637, EP115638, EP115639, EP115640, EP115641, EP115642, EP115643, EP115644, EP115646, EP115647, EP115648, EP115649, EP115650, EP115651, EP115652, EP115653, EP115654, EP115655, EP115656, EP115657, EP115658, EP115659, EP115660, EP115661, EP115662, EP115663, EP115664, EP115665, EP115666, EP115667, EP115668, EP115669 EP115670, EP115671, EP115672, 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. |
Recalling Firm/ Manufacturer |
Advanced Sterilization Products 33 Technology Dr Irvine CA 92618
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For Additional Information Contact |
888-783-7723
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Manufacturer 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.
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FDA Determined Cause 2 |
Component design/selection |
Action |
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. |
Quantity in Commerce |
1,578 units installed in the US and 367 units installed internationally |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = FEB and Original Applicant = AMERICAN ENDOSCOPY, INC.
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