{ "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": "204305", "product_res_number": "Z-0548-2024", "event_date_initiated": "2023-10-05", "event_date_posted": "2023-12-14", "recall_status": "Open, Classified", "res_event_number": "93084", "product_code": "GWM", "k_numbers": [ "K210993", "K232890" ], "product_description": "CereLink ICP Extension Cable (Extension Cable), Model No. 826845\n\nUsed with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 826820/826820P. Cable is also provided with monitor as part of the same SKU.", "code_info": "UDI-DI 10381780520665\n\nAll lots distributed", "firm_fei_number": "3003418325", "recalling_firm": "Integra LifeSciences Corp.", "address_1": "1100 Campus Rd", "city": "Princeton", "state": "NJ", "postal_code": "08540-6650", "additional_info_contact": "Lacey Gigante\n609-212-9004", "reason_for_recall": "Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to include all CereLink ICP Extension Cables. The updated corrective action includes a design change to the extension cable to address the \"out of range readings\" issue.", "root_cause_description": "Device Design", "action": "On October 5, 2023, the firm issued an updated letter, intended to replace the notification sent on June 22, 2022 for the out-of-range readings issue (RES 90457). As an output of the root cause and failure investigation, the design of the extension cable is being modified to incorporate a solution to address the \"out of range readings\" issue.\n\nThe firm instructed customers to return all existing CereLink ICP Extension Cables in their inventory. This includes all CereLink ICP Extension Cables included with the monitor AND all CereLink ICP Extension Cables provided separately.\n\nCustomers should check their inventory and quarantine any affected product.\n\nOnce the firm receives the customer's response form, the firm will provide instructions to return the product.\n\nCustomers with questions about this recall should contact their Account Manager.", "product_quantity": "4941", "distribution_pattern": "US distribution nationwide to the following states: AL\n AR\n AZ\n CA\n CO\n CT\n DC\n DE\n FL\n GA\n IA\n KY\n LA\n MA\n ME\n MN\n ND\n NE\n NH\n NJ\n NY\n OK\n PA\n RI\n TN\n TX\n UT\n VA\n WI\n WV\n\n\nOUS distribution to Australia/New Zealand, Canada, and Europe/Middle East/Africa.", "openfda": { "k_number": [ "K003759", "K896834", "K173192", "K002765", "K912139", "K013930", "K050702", "K113088", "K183406", "K112017", "K051599", "K153347", "K083378", "K883881", "K862012", "K032337", "K853770", "K201118", "K252241", "K822636", "K945585", "K200456", "K802137", "K802100", "K061640", "K121159", "K772063", "K862820", "K071505", "K980380", "K130529", "K914735", "K200630", "K840999", "K790920", "K930221", "K914479", "K962928", "K022638", "K103206", "K040235", "K854657", "K201989", "K882286", "K982702", "K232890", "K010422", "K822864", "K102875", "K172209", "K240821", "K992591", "K171666", "K162108", "K840003", "K050720", "K250285", "K131184", "K022553", "K020780", "K062584", "K120252", "K060554", "K020285", "K042728", "K863479", "K844566", "K940648", "K802149", "K031086", "K802138", "K931609", "K072379", "K133754", "K161010", "K152670", "K813440", "K102077", "K981846", "K890468", "K182073", "K002392", "K053244", "K003905", "K991222", "K884823", "K883518", "K071984", "K974088", "K983799", "K883115", "K943987", "K801755", "K101133", "K882552", "K121573", "K880154", "K893395", "K141869", "K013705", "K853864", "K020558", "K881183", "K210993", "K041838" ], "registration_number": [ "3013886523", "3002808022", "3002108226", "3017180827", "3006240422", "3043513133", "2011171", "9612501", "3007029079", "3023074935", "8010468", "3018094310", "3023852420", "3028006458", "3002807315", "3007156625", "3005067367", "2029275", "3012266672", "3023540124", "2032112", "3003418325", "3004920696", "3004070722", "3027605168", "3011689956", "3003733874", "1526863", "9617601", "9611274", "3004114361", "3003730855", "9616567", "3014334038", "3006697299", "1836324", "3024673", "3009171251", "3006946348", "2183744", "3008114965", "3008102042", "3008791915", "3012507533", "2024024", "2916714", "1220477", "3010611950", "2030624", "3009865268", "3010948104", "3004593495", "3007603826", "3001587388", "3013944123", "1721983", "2023988", "3013557562", "2953359", "3006942548", "3003851947", "3015531529", "3042902796", "3017636737", "3014255018", "3015151147", "3044156918" ], "fei_number": [ "3013886523", "3002808022", "3002108226", "3017180827", "3003495548", "3043513133", "2011171", "3003076831", "3007029079", "3023074935", "3018094310", "3023852420", "3028006458", "3002807315", "3012266672", "3002924544", "3023540124", "3003418325", "3004920696", "1000306431", "3004070722", "3011689956", "3003733874", "3002808043", "3006759904", "1526863", "3004114361", "3002534070", "3003730855", "3002963732", "3014334038", "3006697299", "3024673", "3006946348", "2183744", "3008114965", "3000215205", "3008791915", "3012507533", "2024024", "2916714", "3000206435", "1220477", "3010611950", "3004593495", "3009865268", "3010948104", "3007603826", "3001587388", "3002806577", "3013944123", "2023988", "3013557562", "3002998595", "1000064530", "3006942548", "3003851947", "3015531529", "3042902796", "1625382", "3008133910", "3017636737", "3014255018", "3015151147", "3546", "3044156918" ], "device_name": "Device, Monitoring, Intracranial Pressure", "medical_specialty_description": "Neurology", "regulation_number": "882.1620", "device_class": "2" } } ] }