{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "198468", "product_res_number": "Z-1245-2023", "event_date_initiated": "2023-01-30", "event_date_posted": "2023-03-10", "recall_status": "Open, Classified", "res_event_number": "91671", "product_code": "DSY", "k_numbers": [ "K131778" ], "product_description": "Fusion Bioline Vascular Graft, Part number M00201503046B0", "code_info": "UDI-DI 00384409005942\nLot 25162546", "firm_fei_number": "2242352", "recalling_firm": "Maquet Cardiovascular, LLC", "address_1": "45 Barbour Pond Dr", "city": "Wayne", "state": "NJ", "postal_code": "07470-2094", "additional_info_contact": "Jessica Minaya\n973-709-7634", "reason_for_recall": "One (1) Fusion Bioline Vascular graft from lot 25162546, which failed guideline straightness testing, was intermingled with lot 25162549 and distributed to customers. Use of the affected graft may result in reduction of blood flow or unwanted tension causing bleeding and the formation of a pseudo-aneurysm.", "root_cause_description": "Process control", "action": "On January 30, 2023, the firm notified customers via Urgent Medical Device Removal letters.\n\nCustomers are asked to examine your inventory immediately for lot 25162546.\n\nPlease note, the Lot number appears on the device shelf boxes only.\n\nIf you have the affected lot, please stop using and remove the device from areas of use. You are entitled to a replacement at no cost to your facility. You will receive replacement upon your acknowledgement that you have product for return.\n\nDistributors who have shipped this product should notify their customers.\n\nPlease contact Getinge Customer Service at 888-943-8872 between the hours of 8:00 a.m. and 6:00 p.m. Eastern\nStandard Time to request a return authorization (RMA) and shipping instructions to return any affected product.", "product_quantity": "1 (US)", "distribution_pattern": "US Nationwide distribution in the states of FL, IN, LA, MI, MO, NC, NV, NY, PA, TN, TX, VA, WA.", "openfda": { "k_number": [ "K901682", "K802095", "K961847", "K810376", "K043552", "K022242", "K102596", "K961134", "K991027", "K894732", "K905270", "K964197", "K241550", "K881283", "K061626", "K770235", "K910864", "K954582", "K984294", "K094044", "K871110", "K103347", "K853725", "K050049", "K060142", "K984182", "K760092", "K231972", "K991813", "K232312", "K131778", "K090987", "K862697", "K962433", "K941981", "K141124", "K955588", "K991602", "K832806", "K962639", "K822633", "K964959", "K791828", "K130215", "K854845", "K940062", "K760130", "K880041", "K960706", "K893459", "K130142", "K162803", "K013651", "K051312", "K914116", "K970843", "K020767", "K964625", "K811510", "K252445", "K801621", "K933943", "K964665", "K971192", "K010516", "K060124", "K241070", "K012952", "K831865", "K060741", "K925123", "K091778", "K093817", "K880040", "K933987", "K922025", "K240083", "K172637", "K990503", "K083169", "K882289", "K231505", "K992443", "K830543", "K912911", "K034010", "K041528", "K252277", "K760091", "K993667", "K122138", "K183613", "K952293", "K905269", "K862739", "K861808", "K051332", "K981079", "K992960", "K955230", "K910866", "K810845", "K013250", "K032900", "K922905", "K903931", "K121532", "K983819", "K130016", "K933590", "K811441", "K896964", "K953288", "K801156", "K944858", "K841596", "K904282", "K233551", "K833716", "K820696", "K940816", "K180957", "K002007", "K013577", "K770236", "K882314", "K905067", "K013022", "K071778", "K052964", "K004011", "K890182", "K820600", "K093934", "K831822", "K052282", "K760090", "K884083", "K142062", "K153523", "K983064", "K914447", "K771819", "K821158", "K062161", "K150389", "K955460", "K890597", "K202703", "K030999", "K963790", "K830016", "K091491", "K203724", "K092863", "K000499", "K213845", "K910863", "K901641", "K903964", "K910865", "K913143", "K870884", "K831880", "K933204", "K983861", "K202471", "K233783", "K880167", "K120006", "K221628", "K992832", "K162794", "K853101", "K021547", "K001927", "K071923", "K113101", "K854431", "K124039", "K955532", "K040829", "K821716", "K990800", "K800149", "K010517", "K803000", "K812248" ], "pma_number": [ "P840029" ], "registration_number": [ "3010162973", "1720929", "3015225571", "3010097171", "1721504", "3015309643", "1723241", "2020394", "1721676", "2246552", "3011175548", "9612515", "3045042524", "3033589330", "1640201", "3006950086", "1220477", "2242352", "3008307705", "3010407203", "1018233", "1724474", "3013718163", "3006082230", "3012536737", "1220948", "3007676031", "2017233" ], "fei_number": [ "1000517719", "1720929", "3002707083", "3015225571", "3010097171", "1721504", "3015309643", "2020394", "1721676", "2246552", "3011175548", "3045042524", "3033589330", "3002808437", "3006950086", "1220477", "2242352", "3008307705", "3002807041", "3003094851", "3010407203", "1018233", "3013718163", "3006082230", "3012536737", "1220948", "3007676031", "2017233" ], "device_name": "Prosthesis, Vascular Graft, Of 6mm And Greater Diameter", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.3450", "device_class": "2" } } ] }