{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "48642", "product_res_number": "Z-0171-2007", "event_date_initiated": "2006-10-12", "event_date_posted": "2006-11-14", "recall_status": "Terminated", "event_date_terminated": "2007-11-28", "res_event_number": "36430", "product_code": "KDI", "k_numbers": [ "K041726" ], "product_description": "Asahi APS Series Multiple-Use Hollow Fiber Dialyzers; a wet model multiple use dialyzer consisting of hollow fiber membranes of polysulfone housed within a plastic casing of styrene butadiene block polymer, filled at the factory with fluid to facilitate priming by the user, and sterilized by gamma radiation before shipment; Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Made in Japan; 12 units per case; Models APS-18R and APS-900S - 1.8 m2 surface area, Model APS-21R and APS-1050S - 2.1 m2 surface area", "code_info": "Model APS-18R, Model APS-900S, Model APS-21R and APS-1050S, all lots", "firm_fei_number": "1000599821", "recalling_firm": "Asahi Medical Co., Ltd", "address_1": "3100 Dundee Rd Ste 201/202 201/202 dundee rd ste", "city": "Northbrook", "state": "IL", "postal_code": "60062-2437", "additional_info_contact": "Ms. Karen Borling, R.N.\n847-498-8500", "reason_for_recall": "There have been reports of difficulty separating the Gambro Cartridge Blood Set from Asahi Reuse/Multiple Use Dialyzers at the end of treatment, possibly damaging the dialyzer nozzle.", "root_cause_description": "Other", "action": "Asahi sent Safety Alert letters on 10/12/06 to their re-use dialyzer customers advising them of the reports of difficulty separating the blood set from the dialyzer and not to use the Gambro Cartridge Blood Set with Asahi Reuse/Multiple Use Dialyzers in a reuse situation. Enclosed were copies of the temporary revision Instructions For Use with the following warning added at the top of the page: 'Additional Warning for Reuse/Multiple Use Dialyzers: Ashai Reuse/Multiple use dialyzers must not be used in connection with the Gambro cartridge Blood Set in a reuse environment.' Any questions were directed to Karen Borling, RN at 847-498-8500.", "product_quantity": "100,000 for all models", "distribution_pattern": "Nationwide", "openfda": { "k_number": [ "K003498", "K923727", "K811830", "K071854", "K834589", "K062079", "K946279", "K823881", "K040255", "K994198", "K062922", "K041424", "K914020", "K063183", "K820243", "K120017", "K053539", "K902837", "K991520", "K050603", "K210575", "K242155", "K162488", "K140191", "K173972", "K971180", "K232171", "K193482", "K023224", "K050609", "K830284", "K980386", "K261267", "K082414", "K012510", "K140526", "K101715", "K895759", "K040696", "K031378", "K231125", "K002277", "K090682", "K003023", "K091978", "K002210", "K933883", "K243237", "K133299", "K080650", "K864169", "K926568", "K003425", "K001156", "K080519", "K190793", "K093379", "K133547", "K982414", "K023509", "K043244", "K955384", "K945596", "K170790", "K840449", "K013733", "K131050", "K034064", "K964922", "K192707", "K923139", "K900018", "K041726", "K131908", 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"K931720", "K243874", "K222952", "K960474", "K890315", "K103832", "K933818", "K183158", "K252459", "K812575", "K952983", "K171331", "K233335", "K070643", "K113023", "K801731", "K992563", "K143313", "K992564", "K153449", "K980656", "K910236", "K830596", "K892262", "K070320", "K855251", "K841152", "K083460", "K122347", "K131935", "K926373", "K800536", "K011537", "K080964", "K023874", "K823288", "K030974", "K901286", "K253412", "K992275", "K870724", "K001250", "K150708", "K123395", "K050952", "K061519", "K123262", "K201809", "K233798", "K955487", "K883407", "K002512", "K863823", "K914363", "K844790", "K010985", "K013418", "K240394", "K993064", "K051187", "K951344", "K030975", "K952982", "K021732", "K854011", "K924437", "K982760", "K871108", "K050525", "K883195", "K850979", "K113427", "K232776", "K152367", "K193542", "K192928", "K000028", "K211370", "K212216", "K973322", "K040489", "K051520", "K030592", "K093069", "K120505", "K982134", "K854309", "K050727", "K961465", "K832645", "K103564", 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"Dialyzer, High Permeability With Or Without Sealed Dialysate System", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5860", "device_class": "2", "registration_number": [ "9615942", "1225714", "3008307705", "3017552925", "3004201412", "8030665", "3014272786", "3031565407", "3003504604", "3012102437", "3027592507", "3010377171", "3020689844", "3005941719", "3016250252", "3010355846", "3006174295", "3005695808", "1721676", "1649518", "9610987", "3007137787", "3009128476", "8010182", "3040314808", "3000247873", "2032098", "9610270", "3038195011", "3004111573", "9680579", "3013764800", "9610825", "3015335038", "9612052", "3013536188", "3015136750", "3002807408", "8041145", "3013557562", "1713747", "3005578748", "1000286794", "3003589956", "3008102042", "3013188547", "3003661577", "3015472042", "8031561", "3014300273", "3006755813", "2183744", "3033903155", "3035708507", "9680841", "3015349756", "9681465", "3012149633", "3002879653", "9616074", 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