{ "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": "123941", "product_res_number": "Z-0397-2014", "event_date_initiated": "2013-11-18", "event_date_posted": "2013-11-26", "recall_status": "Terminated", "event_date_terminated": "2014-02-06", "res_event_number": "66882", "product_code": "JXG", "k_numbers": [ "K792005", "K792007", "K841442" ], "product_description": "CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022;\nCSF-Unitized Shunt, Contoured Regular, Medium Pressure, Catalog No. 46024; CSF-Unitized Shunt, Contoured Regular, High Pressure,\nCatalog No. 46026.\n\nCSF-Unitized Shunt Kits are designed as integrated CSF-Flow Control Shunts for use in shunting cerebrospinal fluid from the lateral ventricle of the brain into the peritoneal cavity.", "code_info": "Lot Numbers:  Catalog No. 46022: D27162; D30984; D3461 0; D35834; D37761; D39054; D39539.  Catalog No. 46024: D13944; D14093; D14217; D14216; D33526; D39540.  Catalog No. 46026: D35572; D39583.", "firm_fei_number": "3015531529", "recalling_firm": "Medtronic Neurosurgery", "address_1": "125 Cremona Dr", "city": "Goleta", "state": "CA", "postal_code": "93117-3083", "additional_info_contact": "805-571-8445", "reason_for_recall": "Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.", "root_cause_description": "Other", "action": "Medtronic Neurosurgery sent an Urgent Medical Device Recall letter dated November 18, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to provide a copy of the letter to all those who need to be aware of the matter within their organization or to any organization where the potentially affected product may have been transferred. Customers with questions were instructed to call 805-571-8725.", "product_quantity": "288 units total (147 units in US)", "distribution_pattern": "Worldwide Distribution - USA (nationwide) and Internationally to US and worldwide: Austria, Belgium, Bosnia, Herzegovina, Canada, Croatia, Germany, Japan, Poland, Portugal, Taiwan, United Arab Emirates, United Kingdom.", "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", "K112156", "K990256", "K984583", "K911433", "K823503", "K042825", "K760785", "K954021", "K161605", "K110206", "K122118", 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