{ "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": "161254", "product_res_number": "Z-0645-2018", "event_date_initiated": "2018-01-16", "event_date_created": "2018-02-20", "recall_status": "Terminated", "event_date_terminated": "2020-08-21", "res_event_number": "79058", "product_code": "DTN", "k_numbers": [ "K936003" ], "product_description": "Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540\n\nThe AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood is collected and de foamed while cardiotomy blood is collected, de foamed and filtered before mixing with the venous blood. The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with filter is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures for up to 6 hours in duration.", "code_info": "All lots", "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": "Possible sterile barrier breach in the pouch of Affinity NT Cardiotomy Venous Reservoir stand alone uncoated and Affinity NT Cardiotomy Venous Reservoir stand alone Trillium coated products.", "root_cause_description": "Process control", "action": "Medtronic sent an Urgent Medical Device Recall Letter dated January 16, 2018. \n\nCustomer Actions:\nPlease review your inventory for product affected by this issue.\n1.) Immediately identify and quarantine all unused, non-expired, affected product in your inventory.\n\n2.) Return all unused, affected product in your inventory to Medtronic by contacting Customer Service at\n1-800-854-3570 Option 4, or accessing My Orders and referencing this communication to initiate a return and credit of unused product. Your Medtronic sales representative can assist you in the return of affected product as necessary.\n\n3.) Complete the enclosed Customer Confirmation Certificate and scan and email to RS.CFQFCA@medtronic.com.\n\nThis notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected products have been transferred. For further questions, please call (763) 526-2494.", "product_quantity": "8644 units", "distribution_pattern": "Worldwide Distribution - US Distribution and to the countries of : Australia, Canada, Colombia, Denmark, Germany, Guyana, Israel, Italy, Japan, Netherlands, Norway, Saudi Arabia and United Kingdom.", "openfda": { "k_number": [ "K012942", "K844367", "K991973", "K001602", "K920774", "K884872", "K832802", "K003551", "K964973", "K872720", "K854841", "K934847", "K913956", "K040023", "K122914", "K021287", "K132166", "K251783", "K031700", "K051606", "K823272", "K161733", "K780517", "K993001", "K843595", "K802119", "K812008", "K984586", "K905818", "K945065", "K926250", "K072697", "K883923", "K141233", "K790635", "K170583", "K842391", "K872722", "K992599", "K002238", "K980935", "K061527", "K831966", "K140321", "K241053", "K841031", "K893705", "K933713", "K883345", "K872721", "K911876", "K050111", "K972017", "K971669", "K112771", "K842620", "K770036", "K832924", "K002496", "K083131", "K913915", "K964908", "K982223", "K844229", "K984456", "K070605", "K081947", "K955046", "K915737", "K862357", "K030726", "K843232", "K934763", "K833479", "K841938", "K100507", "K022281", "K812455", "K935717", "K102919", "K770546", "K893711", "K971105", "K890077", "K852382", "K990239", "K090534", "K033714", "K031150", "K936003", "K841175", "K001822", "K870829", "K913692", "K842711", "K802890", "K844366", "K011864", "K131103", "K033641", "K841079", "K894664", "K911790", "K091062", "K882414", "K980786", "K903632", "K936286", "K843888", "K872378", "K941215", "K151110", "K862920", "K933481", "K024065", "K925046", "K241206", "K132972", "K821442", "K760823", "K013526", "K153143", "K953821", "K090690", "K920312", "K781577", "K882720", "K930154", "K930299", "K820727", "K994389", "K070839", "K902631", "K982136", "K092315", "K030449", "K920178", "K895356", "K832671", "K873423", "K904040", "K882380", "K033800", "K896414", "K971013", "K851401", "K915573", "K803059", "K061743", "K864895", "K851376", "K141432", "K823205", "K082082", "K872719", "K813268", "K974155", "K961836", "K936183", "K981284", "K964907", "K895076", "K834373", "K050195", "K981628", "K842337", "K223361", "K871775", "K812009" ], "registration_number": [ "9680841", "9612051", "3007829657", "3015136750", "2011171", "3009746061", "3019807891", "1718850", "3004548776", "2029275", "1625519", "1643817", "9617601", "3030125051", "3003661577", "1047843", "3011554160", "3004080795", "3010084488", "1928237", "8010026", "2184009", "1319639", "9681834", "3008307705", "3003752502", "3002806603", "1724474", "3016746283", "1124841", "3005941719", "3044156918" ], "fei_number": [ "1000116158", "3007829657", "1000138054", "2011171", "3015136750", "3009746061", "3019807891", "1718850", "3000204839", "3004548776", "1625519", "1643817", "1000306431", "3030125051", "3003661577", "3002534070", "1047843", "2828", "3011554160", "3005426550", "3004080795", "3010084488", "3003094851", "1928237", "3002808327", "3002806457", "3008307705", "3003752502", "3002806603", "3016746283", "3002807111", "3044156918" ], "device_name": "Reservoir, Blood, Cardiopulmonary Bypass", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.4400", "device_class": "2" } } ] }