{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "73828", "product_res_number": "Z-0287-2009", "event_date_initiated": "2008-08-06", "event_date_posted": "2008-11-09", "recall_status": "Terminated", "event_date_terminated": "2009-06-16", "res_event_number": "49571", "product_code": "DTZ", "k_numbers": [ "K782095" ], "product_description": "NAMIC Custom Angiographic Kit, Right Heart Kit, REF/Catalog # 60190254, Sterile, and bulk Non-Sterile Manifolds Assemblies, Product #s 40338200 and 40336200 (foreign product for further processing, e.g., packaging, labeling, sterilization, and distribution under BSC). Manufactured by: Boston Scientific Corporation/NAMIC Technology Center/Glens Falls, New York 12801. \n\nAngiographic Manifolds are intended for use in fluid management and/or invasive pressure monitoring systems. Procedures in which angiographic manifold may be used include hemodynamic pressure monitoring and intra-arterial and intravenous administration of water based solutions or radiographic contrast media.", "code_info": "UPN/Material #H749601902540, and Lot/Batch # 1280052 (domestic product), Lot/Batch #s and 1275834, 1276658, and 1278843 (foreign)", "firm_fei_number": "3017892510", "recalling_firm": "Navilyst Medical", "address_1": "10 Glens Falls Tech Park", "city": "Glens Falls", "state": "NY", "postal_code": "12801", "additional_info_contact": "Mr. David Greer\n518-742-4519", "reason_for_recall": "Firm became aware that a specific batch of the product may contain loose plastic particulates in the fluid pathway.", "root_cause_description": "Process design", "action": "On 8/12/08, Navilyst Medical sent a fax and phoned the sole domestic hospital account that had received the affected units. Navilyst Medical instructed the consignee to immediately locate, segregate, and quarantine the units. The hospital consignee confirmed that all units were still in their control and that they will maintain them in quarantine awaiting return to Navilyst Medical. The sole international account, Boston Scientific in Ireland was notified of the problem on 8/06/08. This was followed up with an Urgent Medical Device Recall Letter and Verification Form sent via FedEx on 8/20/08.", "product_quantity": "Domestic - 20 units; Foreign - 16,200 bulk units", "distribution_pattern": "Worldwide Distribution --- USA including state of MO and country of Ireland.", "openfda": { "k_number": [ "K062381", "K100278", "K082403", "K092895", "K830639", "K013038", "K897068", "K912079", "K923272", "K010478", "K962667", "K953835", "K153140", "K874841", "K941653", "K823125", "K892664", "K140774", "K231982", "K864235", "K841476", "K191444", "K090450", "K780078", "K823273", "K991737", "K183511", "K100645", "K842908", "K792039", "K143073", "K130520", "K901249", "K951247", "K121229", "K964043", "K093522", "K872133", "K022115", "K790406", "K090449", "K973760", "K151713", "K920889", "K863476", "K040210", "K230640", "K932252", "K122254", "K130333", "K250821", "K122827", "K241352", "K883053", "K033323", "K102464", "K984271", "K191246", "K833518", "K010443", "K202206", "K031903", "K823343", "K130433", "K931444", "K150267", "K830327", "K130359", "K873923", "K854045", "K800555", "K831122", "K851035", "K934292", "K051997", "K153213", "K090689", "K080708", "K823456", "K231652", "K222297", "K860539", "K901624", "K890808", "K153295", "K790356", "K031223", "K961530", "K894103", "K150489", "K772237", "K180950", "K000255", "K101153", "K801240", "K140177", "K863515", "K172626", "K803231", "K863249", "K203111", "K911227", "K072362", "K894630", "K892641", "K974812", "K861177", "K781842", "K014080", "K954850", "K130493", "K891687", "K183490", "K894826", "K013915", "K912920", "K130209", "K162896", "K861641", "K242503", "K844901", "K903436", "K071774", "K810532", "K123314", "K895632", "K894970", "K802720", "K072091", "K781223", "K211495", "K240934", "K000430", "K990103", "K974085", "K893704", "K882892", "K020351", "K895393", "K843956", "K872107", "K132829", "K113626", "K960074", "K912655", "K030264", "K112360", "K822803", "K253838", "K880021", "K142784", "K071572", "K130280", "K121909", "K172984", "K231773", "K961734", "K120185", "K862918", "K190690", "K980974", "K073380", "K964967", "K891230", "K860673", "K022450", "K912082", "K961000", "K203424", "K933586", "K201916", "K813255", "K020997", "K061628", "K240666", "K993772", "K850630", "K925075", "K001021", "K953976", "K013480", "K803003", "K090511", "K023381", "K853080", "K992559", "K893207", "K926226", "K802719", "K141492", "K831895", "K223161", "K853251", "K901253", "K922799", "K180448", "K910107", "K922933", "K191029", "K810505", "K941473", "K912078", "K833078", "K133261", "K925626", "K050447", "K941225", "K821477", "K201642", "K121536", "K151389", "K925076", "K883054", "K061031", "K004001", "K200683", "K991452", "K833253", "K896978", "K901250", "K896671", "K992910", "K200109", "K831705", "K962641", "K103191", "K083021", "K971877", "K821216", "K151791", "K082117", "K162016", "K833670", "K212341", "K772284", "K802328", "K122844", "K970463", "K843955", "K760824", "K202510", "K140181", "K231414", "K102109", "K963518", "K811004", "K812660", "K810470", "K926467", "K071494", "K831894", "K172071", "K043323", "K802970" ], "registration_number": [ "3030125051", "3010155661", "3009507273", "3010163695", "3021599320", "3008307705", "1218444", "9681834", "3044156918", "2011171", "3002806603", "1643817", "1124841", "3005941719", "2916596", "3045892899", "2184009", "3011554160", "3003752502", "3014990448", "1319639", "2528981", "8010026", "9680841", "3019807891", "3002807090", "3013267343", "3016746283", "1928237", "1220648", "8010762", "1625519", "3015136750", "9617601" ], "fei_number": [ "3002534070", "3030125051", "3010155661", "1000138054", "3009507273", "3010163695", "3005426550", "3021599320", "3008307705", "3002808327", "1218444", "3044156918", "2011171", "3002806603", "1643817", "2916596", "3045892899", "3011554160", "3003752502", "3009649876", "3002807111", "3014990448", "2528981", "2828", "3019807891", "3013267343", "3016746283", "1928237", "1000116158", "1220648", "3000204839", "3006003617", "1625519", "3015136750" ], "device_name": "Oxygenator, Cardiopulmonary Bypass", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.4350", "device_class": "2" } } ] }