{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "38101", "product_res_number": "Z-0788-05", "event_date_initiated": "2005-03-31", "event_date_posted": "2005-05-03", "recall_status": "Terminated", "event_date_terminated": "2006-07-10", "res_event_number": "31536", "product_code": "KDI", "k_numbers": [ "K983720" ], "product_description": "Asahi AM-BIO Series Hollow Fiber Dialyzers; a wet model multiple use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose 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 AM-BIO-65 - 1.3 m2 surface area , AM-BIO-75 - 1.5 m2 surface area and AM-BIO-100 - 2.0 m2 surface area", "code_info": "Schein product code 629-6426, Model AM-BIO-65, lot numbers 04191H, 044A4T, 0419H4A4T;  Schein product code 629-3146, Model AM-BIO-75, lot numbers 044L54, 046Q73, 044L546Q73; Schein product code 629-0041, Model AM-BIO-100, lot numbers 044J53, 04616X, 04616X626Y, 04626Y, 04626Y636B, 04636B, 04636B696K, 04696K, 046F6Q, 046F6Q6L6S, 046H6S, 046L6S, 046L6S6M6V, 046M6V, 046M6V6P72, 046P72, 046Q73", "firm_fei_number": "3002806407", "recalling_firm": "Asahi Medical Co Ltd", "address_1": "1-1 Uchiauwaicho,1-Chome 1-Chome Imperial Tower Bldg", "address_2": "14 Flr", "city": "Chiyoda Ku", "country": "Japan", "additional_info_contact": "Mr. Hiroshi Miyazaki\n847-498-8500", "reason_for_recall": "Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis.", "root_cause_description": "Other", "action": "Asahi sent Henry Schein, Inc. a recall letter dated 3/30/05, requesting the recall of the affected lots of Asahi labeled product, and Henry Schein, Inc. recalled the Asahi labeled dialyzers by letter dated 3/31/05, with a copy of the Asahi 3/30/05 letter. The accounts were informed that the dialyzers may have been exposed to temperature variances during distribution, and werw requested to cease distribution/use of the specific lots listed and return them to Henry Schein for credit. The recall was expanded to include the Terumo labeled dialyzers distributed by Asahi by Henry Schein letter dated 4/13/05, accompanied by a Terumo letter dated 4/8/05, sent to the accounts via first class mail on 4/14/05. The instructions were the same as in the 3/31/05 letter. A revised letter dated 4/21/05 was sent on 4/25/05, correcting the Henry Schein product codes involved in the Terumo labeled product. Any questions were directed Asahi Kasei Medical Co. at 847-498-8500.", "product_quantity": "95,129 units", "distribution_pattern": "Nationwide and Puerto Rico", "openfda": { "k_number": [ "K926568", "K982926", "K021615", "K034064", "K160444", "K844790", "K023874", "K013733", "K252377", "K232776", "K992564", "K131935", "K811944", "K000028", "K211370", "K043244", "K193005", "K062922", "K123288", "K112314", "K926373", "K070222", "K203062", "K970446", "K051520", "K150708", "K062090", "K122343", "K000724", "K883407", "K830487", "K870724", "K911094", "K032356", "K050727", "K830596", "K980386", "K973322", "K980859", "K840680", "K093069", "K854309", "K852885", "K900918", "K873887", "K010985", "K003023", "K050609", "K823589", "K113023", "K001422", "K233335", "K062079", "K854586", "K945621", "K190910", "K790827", "K801731", "K872767", "K082515", "K945747", "K210661", "K212216", "K070643", "K823881", "K090682", "K002277", "K884326", "K201809", "K950522", "K890315", "K852251", "K841585", "K952342", "K020858", "K030099", "K871108", "K884365", "K942681", "K061837", "K823338", "K041005", "K933883", "K150880", "K883307", "K010667", "K233557", "K231125", "K133547", "K103564", "K192707", "K261267", "K994267", "K903641", "K832547", "K854011", "K863961", "K131381", "K081313", "K914363", "K072232", "K945595", "K962427", "K233798", "K252459", "K260533", "K955487", "K040696", "K110823", "K071854", "K051187", "K982413", "K192756", "K133299", "K130039", "K041726", "K010131", "K931720", "K093120", "K012510", "K924437", "K003425", "K171671", "K050525", "K243874", "K820243", "K183158", "K954987", "K823288", "K801303", "K213639", "K070320", "K093902", "K952982", "K143482", "K980656", "K222067", "K193670", "K101715", "K014152", "K032431", "K923727", "K895759", "K843014", "K082414", "K992275", "K983085", "K013562", "K973516", "K093379", "K120017", "K240394", "K231534", "K232467", "K910236", "K832659", "K223248", "K884353", "K964922", "K992894", "K121497", "K083158", "K182940", "K123262", "K913950", "K050952", "K853333", "K933818", "K992563", "K840543", "K011269", "K970739", "K013418", "K242053", "K883195", "K850979", "K001156", "K031378", "K991520", "K253518", "K830284", "K250508", "K981681", "K071263", "K952978", "K023224", "K100334", "K103832", "K800536", "K050603", "K011537", "K861106", "K893742", "K850866", "K003498", "K041424", "K063183", "K945542", "K253412", "K982414", "K030975", "K992566", "K923139", "K131516", "K900018", "K955592", "K872456", "K974652", "K001283", "K834589", "K832645", "K864169", "K945620", "K024124", "K831784", "K121341", "K153344", "K160558", "K070512", "K841152", "K042938", "K892262", "K072093", "K923312", "K982760", "K023664", "K071518", "K853510", "K243264", "K002512", "K083460", "K243505", "K970253", "K951344", "K952983", "K193482", "K963203", "K170574", "K830648", "K926379", "K222952", "K801479", "K920757", "K030974", "K961465", "K914020", "K921134", "K951311", "K131050", "K200741", "K993064", "K011221", "K830647", "K111639", "K080964", "K162488", "K083778", "K220721", "K840449", "K895405", "K152367", "K242155", "K023509", "K863823", "K122051", "K002210", "K860938", "K123395", "K982134", "K171331", "K053539", "K902837", "K160881", "K060008", "K230632", "K801480", "K992573", "K974584", "K030592", "K901286", "K962707", "K971180", "K021732", "K911603", "K113427", "K153449", "K243237", "K243920", "K844663", "K220281", "K963440", "K855251", "K080650", "K040255", "K231406", "K945597", "K780527", "K140866", "K990643", "K132602", "K960474", "K162248", "K781464", "K170790", "K013550", "K140526", "K010805", "K830595", "K192928", "K071298", "K994198", "K190793", "K140191", "K193542", "K122347", "K173972", "K945596", "K945625", "K813591", "K091978", "K970591", "K812575", "K811830", "K953996", "K061519", "K120505", "K040489", "K232803", "K030050", "K170469", "K143313", "K861776", "K232171", "K121409", "K210575", "K864587", "K001250", "K131908", "K163530", "K152938", "K093964", "K955384", "K060195", "K946279", "K080519" ], "registration_number": [ "3015136750", "3006755813", "8041145", "3001744144", "3012149633", "3017552925", "3014479313", "1225714", "3035708507", "1047843", "3040314808", "9610987", "9610270", "3020689844", "3016250252", "9610825", "3016678045", "3010383847", "1000312731", "3043014136", "3006174295", "3002807408", "3003504604", "9611823", "9616240", "9612052", "3003464075", "3031565407", "3033903155", "9680579", "3043226252", "9681465", "3004111573", "1056186", "3005695808", "3032828299", "3015335038", "3038138522", "1649518", "9615942", "3008102042", "3009128476", "3015472042", "3010291427", "1000286794", "8030665", "3005941719", "3005162618", "9680841", "3014272786", "3005578748", "3002879653", "3010377171", "3012494290", "3021632375", "3010355846", "8010182", "3000247873", "1721676", "3003589956", "9616074", "9611369", "3013536188", "1713747", "8030639", "3004530184", "3013557562", "3004176176", "3016096143", "3004201412", "3014300273", "3013188547", "8031561", "9611824", "3012102437", "2032098", "3003661577", "3008229990", "3013764800", "3011554160", "3038195011", "2183744", "3027592507", "3008307705", "3003337893", "3014579161", "3007137787", "3015349756", "3014279513" ], "fei_number": [ "3015136750", "3006755813", "3001744144", "3012149633", "3017552925", "1000203464", "3002807744", "3014479313", "3035708507", "3002974635", "3002807204", "1047843", "3005426550", "3040314808", "3020689844", "3016250252", "3016678045", "3012394756", "3010383847", "3002806469", "1000312731", "3043014136", "3006174295", "3002807408", "3002807111", "3003504604", "3002807005", "3003464075", "3031565407", "3033903155", "3001236277", "1000191953", "3043226252", "3002807035", "3004111573", "3032828299", "3005695808", "3015335038", "3038138522", "3009128476", "3015472042", "3003058448", "1527681", "3010291427", "1000286794", "6898", "3014272786", "3005578748", "3002879653", "3010377171", "3012494290", "1000132332", "3021632375", "3002654698", "3010355846", "3002806443", "3000247873", "1721676", "3003589956", "3013536188", "1713747", "3004530184", "3013557562", "3002807196", "3004176176", "3016096143", "3004201412", "3001451489", "3014300273", "3013188547", "3012102437", "3002924544", "3002807710", "3002807721", "3003661577", "3008229990", "3013764800", "3011554160", "3038195011", "2183744", "3027592507", "3002807113", "3008307705", "3002806960", "3003337893", "3014579161", "3007137787", "3015349756", "3014279513" ], "device_name": "Dialyzer, High Permeability With Or Without Sealed Dialysate System", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5860", "device_class": "2" } } ] }