{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "169578", "product_res_number": "Z-0785-2019", "event_date_initiated": "2018-11-27", "event_date_created": "2019-01-29", "recall_status": "Open, Classified", "res_event_number": "81702", "product_code": "CAC", "k_numbers": [ "K803277" ], "product_description": "RESERVOIR \"Y\" ADAPTER, \n(a) BT920\n(b) BT926\n\nSuction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.", "code_info": "BT920: GTIN/UDI Lot/Serial Numbers 10673978522460\t216044420 10673978522460\t216062719 10673978522460\t216438180  BT926: GTIN/UDI Lot/Serial Numbers 10673978522477\t215782209 10673978522477\t215903433 10673978522477\t216034158 10673978522477\t216107790 10673978522477\t216372963 10673978522477\t216438301", "firm_fei_number": "1000116158", "recalling_firm": "Medtronic Perfusion Systems", "address_1": "7611 Northland Dr N", "city": "Brooklyn Park", "state": "MN", "postal_code": "55428-1088", "additional_info_contact": "Joey Lomicky\n763-526-2494", "reason_for_recall": "Medtronic discovered that certain Y-connectors included in the suction lines have exhibited tearing and cracking. These defects could cause the Y-connectors to leak when in use, which could result in potential blood loss and a breach in the circuit.", "root_cause_description": "Process control", "action": "The firm, Medtronic, began notifying US consignees on 27-Nov-2018 via hand delivery to be followed up with a UPS 2-Day communication titled \"URGENT MEDICAL DEVICE RECALL\" to each listed consignee that does not confirm hand delivery. Communications OUS also began 27-Nov-2018 using locally approved methods. The letter described the product, problem and actions to be taken. Customers were requested to do the following: \n1. Identify and quarantine all unused affected product as listed in your inventory.\n2. Return all unused affected product in your inventory to Medtronic. Contact Medtronic Customer Service at 1-800-854-3570 to initiate a product return. Your local Medtronic Representative can assist you in the return and replacement of this product as necessary.\n3. Complete the enclosed Customer Confirmation Certificate and email to\nRS.CFQFCA@medtronic.com.\n\nIf you have any questions about this action, please contact your Medtronic\nrepresentative or call Director, Cardiac and Vascular Group, at 763-526-2513 or email: carlos.j.alfonzo@medtronic.com.", "product_quantity": "1100 units", "distribution_pattern": "Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, France, Germany, Japan, and Sweden.", "openfda": { "k_number": [ "K904041", "K893394", "K871258", "K193361", "K902759", "K904888", "K913773", "K912609", "K024097", "K112245", "K201305", "K982712", "K852178", "K875023", "K862684", "K162423", "K882757", "K872590", "K913247", "K910238", "K910211", "K221722", "K791891", "K221483", "K864374", "K910991", "K963759", "K896858", "K231782", "K920273", "K022348", "K982755", "K210862", "K872160", "K904474", "K831557", "K892819", "K926338", "K043127", "K192368", "K991986", "K904164", "K972894", "K902671", "K043140", "K053000", "K894294", "K082923", "K962689", "K913684", "K041525", "K911656", "K942844", "K897127", "K860306", "K893578", "K984233", "K942791", "K060482", "K940678", "K022167", "K993581", "K852736", "K900299", "K160197", "K892857", "K913181", "K923016", "K973378", "K902059", "K960734", "K103202", "K963098", "K892443", "K931552", "K210089", "K982660", "K962475", "K122262", "K894668", "K912019", "K781552", "K955010", "K802674", "K895297", "K951592", "K881692", "K852425", "K881421", "K772280", "K900325", "K924894", "K101907", "K140205", "K925827", "K932093", "K872162", "K130043", "K881631", "K240426", "K900483", "K970857", "K883058", "K901232", "K014187", "K973627", "K120953", "K022489", "K971274", "K830735", "K914053", "K781550", "K913177", "K982241", "K110782", "K945775", "K180831", "K854301", "K181954", "K140197", "K131553", "K014083", "K842610", "K012406", "K873807", "K871847", "K812292", "K920618", "K020647", "K982650", "K120586", "K963758", "K893218", "K881129", "K781551", "K781553", "K812355", "K871624", "K952224", "K963850", "K031554", "K915130", "K933625", "K884564", "K890171", "K936220", "K964070", "K904515", "K931899", "K831849", "K872158", "K871568", "K012178", "K933960", "K974897", "K241236", "K881350", "K210176", "K872814", "K953118", "K883663", "K861677", "K843821", "K983022", "K902713", "K160735", "K944232", "K970714", "K992723", "K883082", "K903392", "K881683", "K960006", "K101586", "K093535", "K851024", "K884844", "K240584", "K897126", "K904794", "K914119", "K940519", "K932890", "K772196", "K901138", "K893402", "K880162", "K912610", "K872927", "K931106", "K883934", "K912956", "K896857", "K901401", "K811228" ], "registration_number": [ "1718850", "3010291427", "3010009632", "3011175548", "8043817", "3011270181", "3011137372", "3009380063", "1219343", "3020347218", "1064858", "9617601", "3005012805", "3044156918", "3016994551", "3010273872", "9612051", "3011773324", "1526534", "9680143", "3010084488", "9617787", "3004111573", "3010413216", "3011554160", "3004142400", "3008810357", "9611109", "3004548776", "3006654680", "2029275", "3004634229", "3007923088", "9681630", "9680425", "9680841", "2032112", "2029015", "1220477", "9615908", "3004593495", "3010220595", "3015219237", "3019807891", "1836518", "2528981", "2184009", "3031823122", "3010041511", "1928237", "8022032", "3004365956", "1724474", "2011171", "1424263" ], "fei_number": [ "1718850", "3010291427", "3010009632", "1000306431", "3011175548", "3011270181", "3003282181", "3009380063", "1219343", "3005747797", "3020347218", "3008397795", "3005012805", "3044156918", "3002808267", "3016994551", "3010273872", "3002808845", "3003015552", "3011773324", "1526534", "1000116158", "3010084488", "3004111573", "3010413216", "3011554160", "3001717360", "3004142400", "3008810357", "3004548776", "3006654680", "3002806457", "3004634229", "3007923088", "3003094851", "1000160458", "3005426550", "3004593495", "3003261020", "1220477", "3003094575", "3010220595", "3015219237", "3007596547", "3019807891", "2528981", "3031823122", "3003327833", "3003076831", "3010041511", "1928237", "3002807308", "3004365956", "3002534070", "2011171" ], "device_name": "Apparatus, Autotransfusion", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5830", "device_class": "2" } } ] }