{ "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": "169580", "product_res_number": "Z-0786-2019", "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": [ "K812292" ], "product_description": "SUCTION / ANTICOAGULATION ASSEMBLY\n(a) BTC93\n(b) BTC98\n\nSuction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.", "code_info": "BTC93: GTIN/UDI Lot/Serial Numbers 10673978522545\t215691544 10673978522545\t215691545 10673978522545\t215737228 10673978522545\t215737229 10673978522545\t215782206 10673978522545\t215782207 10673978522545\t215816859 10673978522545\t215816860 10673978522545\t215857423 10673978522545\t215857424 10673978522545\t215903431 10673978522545\t215946277 10673978522545\t216245142 10673978522545\t215875581 10673978522545\t215875582 10673978522545\t215875583 10673978522545\t216045172 10673978522545\t216062720 10673978522545\t216107788 10673978522545\t216150361 10673978522545\t216199988 10673978522545\t216238209 10673978522545\t216245141 10673978522545\t216372965 10673978522545\t216372966 10673978522545\t216372967 10673978522545\t216421235 10673978522545\t216421236 10673978522545\t216438179  BTC98: GTIN/UDI Lot/Serial Numbers 10673978522576\t215782205 10673978522576\t215903430 10673978522576\t216034160 10673978522576\t216062718 10673978522576\t216238210", "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": "7587 units", "distribution_pattern": "Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, France, Germany, Japan, and Sweden.", "openfda": { "k_number": [ "K854301", "K972894", "K894668", "K955010", "K914053", "K890171", "K201305", "K861677", "K944232", "K993581", "K852178", "K895297", "K881350", "K900483", "K024097", "K913181", "K160735", "K940678", "K923016", "K101907", "K991986", "K893218", "K101586", "K913177", "K910238", "K864374", "K875023", "K912609", "K912610", "K901138", "K781553", "K893402", "K982241", "K893578", "K960734", "K933625", "K893394", "K902059", "K240584", "K974897", "K960006", "K940519", "K904888", "K210089", "K831849", "K903392", "K925827", "K852425", "K953118", "K781550", "K992723", "K871847", "K933960", "K871568", "K873807", "K920618", "K860306", "K982660", "K883934", "K882757", "K963098", "K900299", "K811228", "K830735", "K872927", "K210862", "K031554", "K912956", "K130043", "K970714", "K082923", "K012178", "K881421", "K872158", "K140205", "K852736", "K842610", "K022489", "K894294", "K812292", "K945775", "K880162", "K931899", "K984233", "K881692", "K982712", "K931106", "K884844", "K952224", "K904515", "K936220", "K911656", "K843821", "K926338", "K871624", "K772196", "K924894", "K180831", "K781551", "K871258", "K904794", "K872814", "K881631", "K963759", "K904041", "K160197", "K902713", "K883663", "K781552", "K022348", "K901232", "K963850", "K872162", "K221722", "K883082", "K897126", "K812355", "K970857", "K862684", "K140197", "K912019", "K851024", "K802674", "K914119", "K060482", "K883058", "K892819", "K896858", "K913247", "K772280", "K982650", "K192368", "K892857", "K110782", "K240426", "K902759", "K983022", "K910211", "K012406", "K931552", "K131553", "K043140", "K791891", "K122262", "K904164", "K910991", "K181954", "K897127", "K103202", "K896857", "K973627", "K020647", "K913773", "K881129", "K902671", "K881683", "K964070", "K241236", "K043127", "K932890", "K093535", "K901401", "K120586", "K210176", "K962475", "K932093", "K221483", "K915130", "K900325", "K053000", "K951592", "K942844", "K892443", "K120953", "K973378", "K014187", "K942791", "K982755", "K884564", "K112245", "K193361", "K162423", "K872160", "K014083", "K831557", "K962689", "K963758", "K971274", "K022167", "K872590", "K231782", "K041525", "K913684", "K920273", "K904474" ], "registration_number": [ "9680841", "9612051", "2011171", "1526534", "2029015", "3011175548", "3019807891", "1718850", "3004548776", "3031823122", "3004142400", "2029275", "2032112", "3011270181", "1219343", "9680425", "3004111573", "9617601", "3020347218", "3004634229", "3010220595", "3004365956", "9681630", "9615908", "3011554160", "8043817", "3010084488", "3016994551", "1928237", "3006654680", "2184009", "1836518", "1064858", "1424263", "3010413216", "3007923088", "3010273872", "8022032", "1220477", "3004593495", "3010041511", "1724474", "9680143", "3005012805", "3008810357", "9617787", "3010291427", "3011137372", "3009380063", "2528981", "3010009632", "3011773324", "9611109", "3015219237", "3044156918" ], "fei_number": [ "1000160458", "1000116158", "2011171", "1526534", "3005747797", "3011175548", "3003076831", "3019807891", "3001717360", "3007596547", "1718850", "3004548776", "3031823122", "3002807308", "3003282181", "3004142400", "3008397795", "1000306431", "3011270181", "1219343", "3004111573", "3004634229", "3020347218", "3010220595", "3004365956", "3002534070", "3003094575", "3011554160", "3005426550", "3002808845", "3010084488", "3016994551", "3003094851", "3006654680", "3003015552", "1928237", "3002808267", "3010413216", "3003261020", "3002806457", "3007923088", "3010273872", "1220477", "3004593495", "3003327833", "3010041511", "3005012805", "3008810357", "3010291427", "3009380063", "2528981", "3010009632", "3011773324", "3015219237", "3044156918" ], "device_name": "Apparatus, Autotransfusion", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5830", "device_class": "2" } } ] }