{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "176448", "product_res_number": "Z-0124-2020", "event_date_initiated": "2019-09-12", "event_date_created": "2019-10-12", "recall_status": "Open, Classified", "res_event_number": "83831", "product_code": "GWM", "k_numbers": [ "K183406" ], "product_description": "Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems.", "code_info": "All systems", "firm_fei_number": "3003418325", "recalling_firm": "Integra LifeSciences Corp.", "address_1": "311 Enterprise Dr", "city": "Plainsboro", "state": "NJ", "postal_code": "08536-3344", "additional_info_contact": "Dr. Patricia Kihn\n717-309-3966", "reason_for_recall": "There is a potential for a progressive decline in observed ICP readings of the monitor during use.", "root_cause_description": "Under Investigation by firm", "action": "On 9/12/19, the customers were notified by a visit from the Sales Representative who delivered a notification letter at that time. The letter, URGENT: VOLUNTARY MEDICAL DEVICE RECALL, dated 9/12/19, included the following instructions:\n\n1. If you have a CereLink ICP monitor, Model #826820, discontinue using the product as soon as clinically possible and remove the product from service.\n2. Your sales representative will facilitate the return of your monitor.\n3. Complete the information on the Acknowledgement Form attached to this letter and either provide it to your sales representative or email or fax as indicated on the form. Keep a copy of the form for your records.\n\nShould you have any questions regarding these instructions, please contact Customer Service\nMonday to Friday 8:00 AM 8:00 PM EST\nUSA: 1-800-654-2873: email: custsvcnj@integralife.com\nOutside USA: 781-565-1401", "product_quantity": "189", "distribution_pattern": "The products were distributed to the following US states: CA, CO, CT, FL, IN, NY, OK, PA, TX, WI, and WV. The products were distributed to the following foreign countries: Australia, Belgium.", "openfda": { "k_number": [ "K854657", "K061640", "K013705", "K172209", "K940648", "K153347", "K862012", "K042728", "K790920", "K201989", "K893395", "K930221", "K896834", "K083378", "K022553", "K232890", "K772063", "K002392", "K003759", "K880154", "K013930", "K914479", "K991222", "K020780", "K072379", "K102077", "K071984", "K152670", "K200630", "K912139", "K945585", "K882286", "K102875", "K041838", "K003905", "K121159", "K201118", "K133754", "K813440", "K002765", "K801755", "K171666", "K200456", "K943987", "K182073", "K250285", "K121573", "K141869", "K053244", "K120252", "K840003", "K992591", "K031086", "K020558", "K853864", "K050702", "K974088", "K022638", "K113088", "K863479", "K161010", "K252241", "K914735", "K010422", "K032337", "K130529", "K883518", "K131184", "K802149", "K183406", "K822636", "K862820", "K890468", "K060554", "K884823", "K980380", "K883881", "K240821", "K112017", "K173192", "K802137", "K931609", "K050720", "K853770", "K040235", "K051599", "K802138", "K062584", "K822864", "K101133", "K983799", "K962928", "K162108", "K981846", "K071505", "K802100", "K210993", "K020285", "K103206", "K844566", "K881183", "K883115", "K882552", "K840999", "K982702" ], "registration_number": [ "3044156918", "3014334038", "3006942548", "3027605168", "3004593495", "3006240422", "2023988", "3014255018", "3007156625", "3013944123", "3011689956", "3017180827", "3003851947", "3010948104", "2030624", "3003418325", "3015151147", "2032112", "3042902796", "1836324", "3006697299", "9616567", "3018094310", "3002807315", "8010468", "1721983", "3001587388", "3007603826", "3013886523", "3004920696", "2183744", "3023074935", "3009171251", "3004070722", "3043513133", "3003730855", "3003733874", "2916714", "3023852420", "3006946348", "9611274", "3008114965", "3009865268", "3012266672", "3008791915", "2011171", "3002808022", "3002108226", "3013557562", "1220477", "2024024", "2953359", "3023540124", "3024673", "3017636737", "1526863", "3012507533", "2029275", "3005067367", "3015531529", "9612501", "3004114361", "3010611950", "3007029079", "3008102042", "9617601", "3028006458" ], "fei_number": [ "3044156918", "3014334038", "3006942548", "3004593495", "2023988", "3014255018", "3013944123", "3002534070", "3011689956", "3017180827", "3003851947", "3010948104", "3003076831", "3003418325", "3008133910", "3015151147", "3042902796", "3006697299", "3002806577", "3018094310", "3002807315", "3001587388", "3007603826", "3000215205", "3013886523", "3004920696", "2183744", "3023074935", "3043513133", "3004070722", "3003730855", "3003495548", "3003733874", "2916714", "3546", "3023852420", "1000064530", "3006946348", "3008114965", "3002963732", "3009865268", "3012266672", "3002808043", "3008791915", "2011171", "3006759904", "3002808022", "3002108226", "3013557562", "1220477", "1625382", "2024024", "3028006458", "3023540124", "3024673", "3017636737", "1526863", "1000306431", "3012507533", "3000206435", "3015531529", "3004114361", "3010611950", "3007029079", "3002998595", "3002924544" ], "device_name": "Device, Monitoring, Intracranial Pressure", "medical_specialty_description": "Neurology", "regulation_number": "882.1620", "device_class": "2" } } ] }