Z-0281-2009

ASP Automatic Endoscope Reprocessor, AER Plus Product Code 20300 and AER with printer Product Code 20301 The...

Name: Z-0281-2009 ASP Automatic Endoscope Reprocessor, AER Plus Product Code 20300 and AER with printer Product Code 20301 The...
Creator: Advanced Sterilization Products
Published: 2008-09-11
License: https://open.fda.gov/license/

Advanced Sterilization Products / initiated 2008-09-11 / Terminated / root cause: design

FDA source

Advanced Sterilization Products began a recall of 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... on 2008-09-11. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0281-2009
Status: Terminated
Initiated: 2008-09-11
Posted: 2008-11-07
Terminated: 2011-12-27
Recalling firm: Advanced Sterilization Products
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.
Product code: FEB Accessories, Cleaning, For Endoscope
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.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: 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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Product code FEB

K832458Class IIAutomatic EndoscopeAmerican Endoscopy, Inc. / cleared 1983-10-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)