{ "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": "118142", "product_res_number": "Z-0864-2014", "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, Unitized Bactiseal Catheter and Accessories\r\n\r\nProduct Code: 82-8807\r\n\r\n\r\nProduct Usage:\r\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:  CLPCNB CMBCPT CMCC2W CMDB6L CMDDJV CMKB24 CMLCKN CMMC3H CMNBZH CNCB6N CNCCLJ CNCCZ3 CNDB8C CNDBRJ CNGBK4 CNHCZR CNJB1G CNJC4T CNJCMR CNKBZD CNLBVM CNLBZC CNMBFL CNNDH1 CNMBFM CNMDNK CNPBRL CNPCLV CPBBGT CNCCLH CNCCZ2 CNDB69 CNDCV0 CPBCR3 CPCBHC CPCBHD CPDCC3 CMMCGV CNBB11 CPBCR4 CPCCMN CPDBYL", "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": "746 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": [ "K984583", "K120559", "K931989", "K081773", "K030081", "K963802", "K974708", "K854474", "K091328", "K984053", "K223330", "K944222", "K003564", "K902257", "K212641", "K854049", "K012052", "K021653", "K122118", "K252514", "K913636", "K200950", "K222471", "K911433", "K090342", "K920156", "K944595", "K233448", "K042359", "K102961", "K921936", "K050739", "K011030", "K902783", "K121248", "K171880", "K973525", "K024101", "K243531", "K903844", "K042465", "K873247", "K033850", "K862303", 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