{ "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": "205998", "product_res_number": "Z-1284-2024", "event_date_initiated": "2024-02-02", "event_date_posted": "2024-03-13", "recall_status": "Open, Classified", "res_event_number": "93955", "product_code": "QJP", "k_numbers": [ "K192804" ], "product_description": "CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: \na) GS9080SD; \nb) GS9090SD; \nc) GS9095SD; \nVascular guide-catheter, single-use", "code_info": "a) GS9080SD: \n\nUPDATED 4/4/2024\n\nUDI-DI 10886704082316, Lot numbers: 31121042, 31133636, 31140739, 31140751, 31146719, 31154809, 31160736, 31174927, 31178955, 31189206, 31194710, 31194733, 31208988, 31212653, 31212661;\n\nb) GS9090SD: \n\nUPDATED 4/4/2024\n\nUDI-DI 10886704082293, Lot numbers: 31094249, 31103843, 31108260, 31116484, 31116485, 31121039, 31121040, 31121043, 31121044, 31133637, 31133638, 31140740, 31140952, 31146720, 31150968, 31150969, 31154810, 31154811, 31160737, 31160738, 31168610, 31168611, 31174928, 31174930, 31178956, 31178957, 31178958, 31189207, 31189208, 31194711, 31194712, 31194734, 31194735, 31204436, 31208989, 31208990, 31208991, 31212654, 31212655, 31212663, 31225738;\n\nc) GS9095SD: UDI-DI 10886704082323, Lot Numbers: 31208992, 31212656", "firm_fei_number": "3008114965", "recalling_firm": "Medos International Sarl", "address_1": "Chemin Blanc 36 36 chemin blanc", "city": "Le Locle", "country": "Switzerland", "additional_info_contact": "G¿nter Solms \n+41 32 934 8472", "reason_for_recall": "Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injury and in extreme rare occasions it may result in embolism.", "root_cause_description": "Under Investigation by firm", "action": "Johnson&Johnson MedTech/DePuy Synthes issued an URGENT: MEDICAL DEVICE RECALL (REMOVAL) notice to its consignees on 02/02/2024 via letter delivered by FedEx. The notice explained the issue and the risk and requested the affected inventory be quarantined and the notice be disseminated to all appropriate personnel. Further instructions state: \n\"Complete the Business Reply Form (BRF) confirming receipt of this notice and scan and email signed form to OneMD-Field-Actions@its.jnj.com or fax it to (305) 265-6889, Attention Line: Cerebase FA2350411. Please return the BRF even if you do not have product subject to this recall. Follow instructions in the letter and immediately call 1-844-483-3882 to return any inventory of CEREBASE DA Guide Sheath devices subject to this recall. To receive credit reimbursement, customers must return product subject to this recall. Attention Line: Cerebase FA2350411\"", "product_quantity": "1343 units", "distribution_pattern": "Worldwide distribution.", "openfda": { "k_number": [ "K260938", "K233982", "K203723", "K230726", "K253975", "K252213", "K202916", "K243593", "K242289", "K251372", "K221951", "K241244", "K213314", "K242033", "K231393", "K221930", "K261808", "K254046", "K200910", "K243577", "K253359", "K213390", "K240948", "K230775", "K234074", "K212402", "K261889", "K233924", "K203764", "K211594", "K254178", "K240711", "K252297", "K200417", "K210635", "K242376", "K222948", "K223560", "K232542", "K231583", "K201518", "K242301", "K221822", "K202926", "K220807", "K192804", "K241388", "K212288", "K203842", "K213451", "K222743", "K202752", "K200121", "K213589", "K230609", "K230322", "K201076", "K231056", "K260199", "K240529", "K253901", "K243297", "K214048", "K242392", "K203840", "K231179", "K212224", "K240746", "K203043", "K233201", "K212838", "K233648", "K242051", "K251097", "K251560", "K241768", "K252569", "K233205", "K251668", "K250960", "K240971", "K201682", "K231218", "K231168", "K212340", "K213065", "K261549", "K251240", "K200206", "K211893", "K253032", "K254223", "K223275", "K251044", "K231802", "K241637" ], "registration_number": [ "", "3013858269", "3013556777", "3014211783", "3024801436", "3002807314", "3007007790", "1064858", "1220477", "3031768596", "3014590708", "3030088112", "3008853977", "3020954126", "1721676", "3014758755", "2024311", "3044156918", "2011171", "3007628272", "3004063494", "3013944123", "9612501", "3005168196", "3012543881", "3013758550", "3008837339", "1048735", "3009546466", "3016522967", "3017278832", "3009965866", "3009380063", "3014644549", "1035166", "3010079067", "3032047719", "3012931345", "9617601", "3031311812", "3017168767", "1721686", "3015453963", "3014779787", "3006451981", "3003775027", "2030624", "3016800412", "3008881809", "3011370111", "2183744", "3017636737", "3039020025", "3012497308", "3015615738", "3015550451", "3009337401", "3014498720", "3014766734", "3000308637", "3019807891", "3014162263", "3006010712", "3008264254", "1047843", "3008824097", "3008114965", "3013656790", "2029214", "2027062", "3016591327", "3025028711", "3027319104", "3017210488", "3003780911", "3015701715" ], "fei_number": [ "", "3013858269", "3013556777", "3014211783", "3024801436", "3002807314", "3007007790", "3002534070", "1220477", "3031768596", "3014590708", "3030088112", "3008853977", "3020954126", "3003495548", "1721676", "3014758755", "2024311", "3044156918", "2011171", "3007628272", "3004063494", "3013944123", "3005168196", "1000220862", "3012543881", "3013758550", "3008837339", "1048735", "3009546466", "3016522967", "3017278832", "3009965866", "3009380063", "3014644549", "1035166", "3010079067", "3032047719", "3012931345", "3031311812", "3017168767", "1721686", "3015453963", "3014779787", "3006451981", "3003775027", "3016800412", "3008881809", "3011370111", "2183744", "3017636737", "3039020025", "3012497308", "3015615738", "3015550451", "3009337401", "3014498720", "3014766734", "3000308637", "3019807891", "3014162263", "3006010712", "3008264254", "1047843", "3008824097", "3008114965", "3013656790", "3008397795", "2027062", "3016591327", "3025028711", "3027319104", "3017210488", "3000206435", "3003780911", "3015701715" ], "device_name": "Catheter, Percutaneous, Neurovasculature", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1250", "device_class": "2" } } ] }