{ "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": "159875", "product_res_number": "Z-0275-2018", "event_date_initiated": "2017-11-03", "event_date_posted": "2017-12-05", "recall_status": "Terminated", "event_date_terminated": "2019-11-04", "res_event_number": "78607", "product_code": "NRY", "k_numbers": [ "K113260", "K113778", "K132641", "K143077", "K151667" ], "product_description": "Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm), MICROCATHETER,150 cm, 6 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm, UPN M0033PK62523002\n\nStroke intervention kit", "code_info": "Lot Numbers: QXC10200044, exp. date 28-Aug-18; QXC10200043, exp. date 28-Aug-18", "firm_fei_number": "3008853977", "recalling_firm": "Stryker Neurovascular", "address_1": "47900 Bayside Pkwy", "city": "Fremont", "state": "CA", "postal_code": "94538-6515", "additional_info_contact": "Angela Beckman\n510-413-2900", "reason_for_recall": "Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs\nwere manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack.", "root_cause_description": "Labeling Change Control", "action": "The firm, Stryker Neurovascular, sent an \"Urgent Medical Device Voluntary Recall Immediate Action Required\" letter initiating their recall on 11/01/2017. The letter described the product, problem and actions to be taken. The consignees were instructed to immediately check internal inventory; remove and discard the procedure pack carton sleeve; circulate notice; maintain awareness of notice internally until all required actions have been completed with your facility; inform Stryker of any subject devices distributed to other organization, and complete and return customer response form to your nominated Stryker Representative or to NVFieldActions@stryker.com.\n\nIf you have any questions, call 510-413-2593; email: geraldine.ahern@stryker.com or 510-413-2900.", "product_quantity": "2 units", "distribution_pattern": "International Distribution to: Germany, Slovakia and Israel.", "openfda": { "k_number": [ "K190338", "K033736", "K161640", "K191946", "K230429", "K160449", "K260002", "K172448", "K230695", "K173761", "K113163", "K243287", "K182101", "K243601", "K211411", "K173841", "K142458", "K153071", "K242104", "K100769", "K063774", "K203592", "K062046", "K242672", "K190212", "K133317", "K233988", "K180008", "K222786", "K061059", "K071172", "K250958", "K253590", "K162901", "K141491", "K254276", "K223530", "K252046", "K202251", "K251015", "K212908", "K250012", "K090085", "K252707", "K072718", "K211120", "K150616", "K232524", "K201689", "K210996", "K243047", "K253062", "K181354", "K161064", "K191768", "K211338", "K251789", "K183464", "K232971", "K251357", "K250690", "K133464", "K173200", "K190010", "K183185", "K161879", "K180705", "K141516", "K211476", "K093610", "K234083", "K081305", "K222808", "K132641", "K120961", "K090752", "K160641", "K223545", "K202182", "K123378", "K151623", "K251603", "K182522", "K183043", "K173452", "K251828", "K070521", "K190464", "K152541", "K122478", "K242504", "K240917", "K143077", "K220808", "K172167", "K082034", "K211654", "K223913", "K233329", "K251006", "K243948", "K203440", "K193380", "K252392", "K193063", "K113455", "K221934", "K243080", "K241221", "K211697" ], "device_name": "Catheter, Thrombus Retriever", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1250", "device_class": "2", "registration_number": [ "3013556777", "3014211783", "3022392708", "3002807314", "3007007790", "3021009035", "1220477", "3031288142", "3014590708", "3030088112", "3008853977", "3020954126", "1721676", "2024311", "3003144120", "2011171", "3007628272", "3010034260", "3021520400", "3005168196", "3012543881", "3013758550", "3008837339", "1048735", "3009546466", "3016522967", "9616664", "3009380063", "3014644549", "3010079067", "3012931345", "3017168767", "3015453963", "3006451981", "2030624", "3009957947", "3015531723", "3016678045", "3008881809", "3011370111", "2183744", "3039020025", "3012497308", "3015615738", "3015550451", "1721504", "3009337401", "3014498720", "3019807891", "3016540856", "3014162263", "3008264254", "2183828", "3008824097", "3008114965", "3013656790", "2029214", "3014590707", "3016591327", "3015701715" ], "fei_number": [ "3013556777", "3004099094", "3014211783", "3002807314", "3007007790", "3022392708", "3021009035", "1220477", "3031288142", "3014590708", "3030088112", "3008853977", "3020954126", "1721676", "2024311", "2011171", "3007628272", "3010034260", "3021520400", "3005168196", "1000220862", "3012543881", "3013758550", "3008837339", "1048735", "3009546466", "3016522967", "3009380063", "3014644549", "3010079067", "3012931345", "3017168767", "3015453963", "3006451981", "3009957947", "3015531723", "3016678045", "3008881809", "3011370111", "2183744", "3039020025", "3012497308", "3015615738", "3015550451", "1721504", "3009337401", "3014498720", "3019807891", "3016540856", "3014162263", "3008264254", "2183828", "3008824097", "3008114965", "3013656790", "3014590707", "3016591327", "3009024869", "3000206435", "3015701715" ] } } ] }