{ "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": "105163", "product_res_number": "Z-0710-2012", "event_date_initiated": "2011-10-25", "event_date_posted": "2012-01-11", "recall_status": "Terminated", "event_date_terminated": "2015-05-29", "res_event_number": "60362", "product_code": "GWM", "k_numbers": [ "K853770" ], "product_description": "Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Plastic Subarachnoid Screw, Pediatric \nProduct Code:80-1197\n\n\nProduct Usage:\nThe Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xylocaine) to allow physicians to access the cranium for various Neurosurgical procedures.", "code_info": "Lot codes: 114474 456961  BA227  LA216", "firm_fei_number": "3002947440", "recalling_firm": "Codman & Shurtleff, Inc.", "address_1": "325 Paramount Drive", "city": "Raynham", "state": "MA", "postal_code": "02767", "additional_info_contact": "508-880-8100", "reason_for_recall": "Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits.", "root_cause_description": "Labeling Change Control", "action": "Codman issued an Urgent Medical Device Correction Notice dated October 25, 2011 to all affected customers. The notice identified the product, problem, and actions to be taken. Customers were instructed to notify all appropriate personnel of the correction notice. The notice instructs customers to fax the attached acknowledgement form to 508-977-6403. For questions call your Customer Service or contact your local Codman representative.", "product_quantity": "254 units", "distribution_pattern": "Worldwide Distribution - USA (nationwide) and the countries of: Dubai, Mexico, Panama, Spain and Uruguay.", "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" } } ] }