{ "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": 78 } }, "results": [ { "cfres_id": "130121", "product_res_number": "Z-0089-2015", "event_date_initiated": "2014-09-15", "event_date_posted": "2014-10-20", "recall_status": "Terminated", "event_date_terminated": "2017-08-11", "res_event_number": "69262", "product_code": "JXG", "k_numbers": [ "K061568" ], "product_description": "Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System)\nCatalog Number: 82-1730\nIndicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated", "code_info": "All lots with expiration on or before August 2017 (2017-08)", "firm_fei_number": "3002947440", "recalling_firm": "Codman & Shurtleff, Inc.", "address_1": "325 Paramount Drive", "city": "Raynham", "state": "MA", "postal_code": "02767", "additional_info_contact": "Same\n508-880-8000", "reason_for_recall": "tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus)", "root_cause_description": "Device Design", "action": "Codman Neuro sent an Urgent Notice dated September 12, 2014, to all affected customers via overnight mailing and OUS customers notified via email the week of September 15, 2014.\nAccounts were requested to isolate all inventory of the affected product and return to Stericycle at the following address:\nStericycle 2670 Executive Drive, Suite A Attn: Event #8894 Indianapolis, IN 46241\nFor patients currently being managed with the EDS 3 System, the system should be replaced immediately. In the case where no substitute drainage system is immediately available, the EDS 3 System may continue to be used until an alternative product can be obtained.\nIf you have any questions or concerns regarding this notification, please contact your local Codman Neuro Representative or Scientific and Medical Affairs at SciMedAffairs@its.jnj.com or (866) 685-7325.\nFor questions regarding this recall call 508-880-8000.", "product_quantity": "66,120 units", "distribution_pattern": "Worldwide Distribution - USA (nationwide) and Internationally to:\nUnited Arab Emirates\nArgentina\nAustria\nAustralia\nAruba\nBelgium\nBahrain\nBolivia\nBrazil\nBahamas\nCanada\nSwitzerland\nChile\nPeople's Republic of China\nColumbia\nCosta Rica\nCyprus\nCzech Republic\nGermany\nAlgeria\nEstonia\nEgypt\nSpain\nFinland\nFrance\nGabon\nGreat Britain\nFrench Guiana\nGreece\nGuatemala\nHong Kong\nCroatia\nHungary\nIreland\nIsrael\nIndia\nIran\nItaly\nJordan\nKenya\nKuwait\nKazakhstan\nLebanon\nLithuania\nLuxembourg\nLatvia\nMauritius\nMexico\nMalaysia\nMozambique\nNew Caledonia\nNigeria\nNetherlands\nNorway\nNew Zealand\nOman\nPanama\nPeru\nPoland\nPalestine\nPortugal\nReunion\nRomania\nSerbia\nRussian Federation\nRwanda\nSaudi Arabia\nSweden\nSingapore\nSlovenia\nSlovakia\nTunisia\nTurkey\nTrinadad And Tobago\nTaiwan\nUkraine\nUruguay\nVenezuela\nMayotte\nSouth Africa", "openfda": { "k_number": [ "K062009", "K000514", "K170599", "K913412", "K251598", "K964923", "K243676", "K974726", "K944222", "K870660", "K080168", "K823509", "K791075", "K843132", "K061568", "K041992", "K875205", "K200950", "K123554", "K930222", "K874508", "K062599", "K853215", "K181902", "K233445", "K960435", "K031097", "K261004", "K091312", "K790126", "K992465", "K800168", "K973774", "K152897", "K914995", "K954285", "K021653", "K895524", "K853366", "K964386", "K222422", "K971617", "K101381", "K231664", 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