{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "118138", "product_res_number": "Z-0862-2014", "event_date_initiated": "2013-05-16", "event_date_posted": "2014-01-29", "recall_status": "Terminated", "event_date_terminated": "2015-06-02", "res_event_number": "65179", "product_code": "JXG", "k_numbers": [ "K112156", "K113526" ], "product_description": "Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Catheter and Accessories\nProduct Code: 82-8805\n\nProduct Usage:\nThe CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.", "code_info": "Lot Codes:  CMBC2Y CMDCN9 CMJC48 CMLC6D CNCCLB CNCCZ4 CNDBRG CNDCNB CNHC8M CNJC4P CNKCL4 CNLCL1 CNMB8Y CNMDM0 CNNDHY CNPCLZ CPBC99 CPCC27 CPDBYJ CMNBFF CMNCDY CNCB6M CPBCRZ CPDCKL", "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\n508-880-8100", "reason_for_recall": "Codman Certas Programmable Valves used for hydrocephalus may not operate properly", "root_cause_description": "Device Design", "action": "Codman issued an Urgent Notice dated May 16, 2013, to all affected customers. The letter identifed the affected product, problem and actions to be taken. Mitigation instructions are provided and if not followed or are not successful, either issue could lead to symptoms associated with under- or over-drainage. Units not implanted are to be returned. A U.S Acknowledgement Form and fax are requested to be completed and faxed to: 1-888-943-4193, or e-mail the form to codman8894@stericycle.com. If you have any questions on concerns in regards to this recall, please contact your Codman Representative or Stericycle at 1-888-943-2395.", "product_quantity": "369 units", "distribution_pattern": "Worldwide Distribution - US Nationwide, Australia, Austria, Belgium, Brazil, Switzerland, Czech Republic, Germany, Spain, Finland, France, Great Britain, Israel, Italy, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa, and UK.", "openfda": { "k_number": [ "K042465", "K172035", "K062599", "K073139", "K242974", "K233445", "K061568", "K955832", "K103003", "K242003", "K110206", "K902257", "K970578", "K222471", "K002476", "K020667", "K150898", "K243676", "K760785", "K960159", "K962990", "K920156", "K003564", "K033017", "K042359", "K121248", "K862303", "K011030", "K803257", "K052386", "K904120", "K221918", "K896167", "K992226", "K791076", "K991502", "K012052", "K992465", "K922941", "K820247", "K854049", "K192266", "K061876", "K984583", 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