{ "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": "94583", "product_res_number": "Z-0161-2011", "event_date_initiated": "2010-09-15", "event_date_posted": "2010-10-28", "recall_status": "Terminated", "event_date_terminated": "2012-04-18", "res_event_number": "56820", "product_code": "GWM", "k_numbers": [ "K040235" ], "product_description": "Licox Brain PMO Probe Kit;\nRef IP2.P;\nMultiparameter Monitoring Oxygen + ICP Channel: Contain Products: REF IP2 Bolt kit for 2 brain probes, Ref CC1.P1 combined Oxygen & Temperature probe;\nContains sterile and non-pyrogenic if package is unopened and undamaged.\nIntegra US, 311 Enterprise Drive, Plainsboro, NJ 08536", "code_info": "Ref IP2P, Lot number: 250210A; Serial Numbers: 833, 834, 835, 836, 837, 838, 839, 841, 844, 846, 847, 848, 850, 851, 852, 853, 854, 855, 857, 858, 859, 860, 861, 862, 864.", "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": "Lauren Moose\n609-216-2978", "reason_for_recall": "Incorrect expiration date - The outer boxes of the IP2P Licox Complete Kit for Cerebral Pressure, Temperature and ICP Monitoring Probes, Lot 250210A are labeled with an incorrect shelf life date (10 months too long).", "root_cause_description": "Employee error", "action": "Integra issued Urgent Product Recall Notification letters dated September 16, 2010 to US customers and foreign consignees, identifying the affected lots and actions to be taken by customers.\nAffected product is not to be further distributed and should be quarantined pending return to the firm. Customers and Distribors should contact Integra Customer Service for a Returned Material Authorization Number, and then return the product to the Distribution Center. In addition, a Recall Acknowledgement and Return Form is to be completed and returned.\nCustomers can contact Integra at 609 936-2495.", "product_quantity": "23kits", "distribution_pattern": "Worldwide Distribution: USA, including the states of FL, ID, IL, and NJ, and the countries of Argentina and Costa Rica.", "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" } } ] }