{ "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": "130098", "product_res_number": "Z-0201-2015", "event_date_initiated": "2014-08-18", "event_date_posted": "2014-11-10", "recall_status": "Terminated", "event_date_terminated": "2016-05-11", "res_event_number": "69251", "product_code": "GWM", "k_numbers": [ "K131184" ], "product_description": "Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamore, County Offaly, Ireland, Distributed by: Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536", "code_info": "Catalogue #LCX02 - Serial #'s 2130901032, 2130901050, 2131001062, 2131001063, 2131001086, 2131001087, 2131001102, 2131001110, 2131001111, 2131001115, 2131101124, 2131101125, 2131101127, 2131101129, 2131101134, 2131101138, 2131101151, 2131101154, 2140101181, 2140301222, 2130901017, 2130901019, 2130901022, 2130901025, 2130901034, 2130901035, 2130901051, 2130901055, 2130901056, 2130901058, 2130901059, 2131001072, 2131001076, 2131001077, 2131001081, 2131001088, 2131001093, 2131001108, 2131101126, 2131101129, 2131101122, 2130901028 and 2130901039; Catalogue #LCX02R - Serial #'s 2130901038, 2130901046, 2130901054, 2131201163, 2131201164, 2131201165, 2131201166, 2131201167, 2140101170, 2140101172, 2140101174, 2140101178, 2140101179, 2140201186, 2140201189, 2140201197 and 2140401227.", "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": "Mr. David E. Gronostajski\n609-936-6822", "reason_for_recall": "Integra LifeSciences Corporation received 2 complaints that the USB port on the Licox Pt02 monitor does not consistently provide the user the ability to extract the Pt02 trend data according to the User's Manual for the device.", "root_cause_description": "Device Design", "action": "Integra LifeSciences sent an \"Urgent Voluntary Medical Device Correction\" letter/Return Response Form dated August 18, 2014, to their affected customers via traceable courier service. The letter identified the product the problem and the action needed to be taken by the customer.\n\nComplete the attached form. If you do not have an affected monitor, check the box: I do not have any monitors with an affected Serial Number listed below.\n\nIf you do have affected monitors, check the box: I do have monitors with an affected Serial Number listed below. Circle all the Serial Numbers\nfor the affected monitors you have and record the total quantity.\n\nComplete the other information on the form and return the form by email or fax as indicated. Keep a copy of the form for your records.\n\nWhen your form is received, Integra will schedule this service with your facility and provide a temporary loaner monitor to minimize any disruption this action may cause.\n\nShould you have any questions, please contact Neuro Customer Service at 1-855-532-1723. We apologize for any inconvenience this may cause and thank you for your cooperation in this effort.", "product_quantity": "43 (LCX02) and 17 (LCX02R)", "distribution_pattern": "US Distribution including the states of : CA, DC, FL, IL, IN, MI, MN, NC, NY, PA and TX", "openfda": { "k_number": [ "K013930", "K802100", "K801755", "K201989", "K141869", "K121573", "K120252", "K862012", "K013705", "K053244", "K912139", "K992591", "K940648", "K962928", "K983799", "K071505", "K200630", "K022638", "K840999", "K981846", "K853864", "K772063", "K002392", "K020780", "K883115", "K041838", "K061640", "K914479", "K840003", "K173192", "K130529", "K822636", "K802149", "K863479", "K890468", "K980380", "K133754", "K974088", "K102875", "K930221", "K152670", "K881183", "K914735", "K844566", "K854657", "K882552", "K802138", "K040235", "K101133", "K862820", "K883881", "K884823", "K010422", "K022553", "K883518", "K931609", "K172209", "K201118", "K183406", "K072379", "K790920", "K853770", "K050702", "K071984", "K020285", "K232890", "K102077", "K250285", "K945585", "K161010", "K882286", "K002765", "K171666", "K083378", "K020558", "K802137", "K113088", "K200456", "K051599", "K982702", "K121159", "K822864", "K003759", "K112017", "K880154", "K131184", "K062584", "K252241", "K943987", "K210993", "K032337", "K991222", "K031086", "K162108", "K103206", "K042728", "K182073", "K050720", "K060554", "K240821", "K896834", "K003905", "K153347", "K893395", "K813440" ], "registration_number": [ "3003730855", "2029275", "3001587388", "3023852420", "1220477", "3012507533", "3009865268", "3006240422", "3008102042", "3042902796", "3018094310", "1836324", "3043513133", "3004070722", "2011171", "3044156918", "3002108226", "3013944123", "3006942548", "3002808022", "9612501", "3011689956", "3015151147", "9616567", "3003851947", "9611274", "3005067367", "3014255018", "2916714", "1721983", "1526863", "9617601", "3002807315", "3017180827", "2024024", "2032112", "3023540124", "2953359", "3010611950", "3013886523", "2030624", "3007156625", "3012266672", "3014334038", "3003733874", "3024673", "2183744", "3017636737", "8010468", "3013557562", "3007029079", "3015531529", "3027605168", "3004114361", "3007603826", "2023988", "3008114965", "3006697299", "3004593495", "3008791915", "3023074935", "3009171251", "3003418325", "3010948104", "3004920696", "3006946348", "3028006458" ], "fei_number": [ "3003730855", "3001587388", "3002534070", "3023852420", "1220477", "3003076831", "3012507533", "3009865268", "3003495548", "3042902796", "3018094310", "3043513133", "3004070722", "2011171", "3044156918", "3002108226", "3013944123", "3006942548", "3002808022", "3011689956", "3015151147", "3003851947", "3002924544", "2916714", "3014255018", "1625382", "1526863", "3002807315", "3017180827", "2024024", "3023540124", "1000064530", "1000306431", "3010611950", "3013886523", "3002998595", "3006759904", "3012266672", "3014334038", "3003733874", "3024673", "2183744", "3017636737", "3546", "3013557562", "3002806577", "3002963732", "3015531529", "3007029079", "3004114361", "3000215205", "3007603826", "2023988", "3008114965", "3006697299", "3004593495", "3008791915", "3023074935", "3006946348", "3003418325", "3010948104", "3004920696", "3002808043", "3008133910", "3000206435", "3028006458" ], "device_name": "Device, Monitoring, Intracranial Pressure", "medical_specialty_description": "Neurology", "regulation_number": "882.1620", "device_class": "2" } } ] }