{ "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": "124553", "product_res_number": "Z-0622-2014", "event_date_initiated": "2013-11-13", "event_date_posted": "2014-01-03", "recall_status": "Terminated", "event_date_terminated": "2015-02-13", "res_event_number": "67025", "product_code": "JXG", "product_description": "Integra Large Rickham -Style Reservoir\nRx Only Sterile for Single Use Only\nIntegra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA\nNL 850-1132\n\nProvides access to the lateral cerebral ventricles via hypodermic puncture. It is useful in obtaining CSF (cerebral spinal fluid_ samples for cytological and chemical studies, for monitoring ventricular fluid pressure and for ventricular drainage. The reservoir provides easy access to the lateral ventricles and to cystic tumors for the injections of chemotherapeutic agents and/or radio-isotopes. The rickham reservoir may be utilized in hydrocephalic patients as a component in systems designed to shunt CSF from the lateral ventricles into either the right atrium of the heart of the peritoneum.", "code_info": "1094085, 1101479, 1101647, 1102403, 1102807, 1104174, 1110043, 1120817, 1130797, 1131331, 1131660", "firm_fei_number": "3003418325", "recalling_firm": "Integra LifeSciences Corp.", "address_1": "311 Enterprise Dr", "city": "Plainsboro", "state": "NJ", "postal_code": "08536-3344", "additional_info_contact": "855-532-1723", "reason_for_recall": "Integra became aware through an adverse complaint trend that Rickham Style Reservoirs with bent or broken connectors that were shipped in sleeve-type packages were found prior to use but after the sterile package was open.", "root_cause_description": "Packaging", "action": "Integra sent an Urgent Voluntary Medical Device Recall letter dated November 13, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory for the affected product and if located stop using immediately. Customers were asked to complete the attached form and return it to Integra as indicated and keep a copy of the form for their records. Once the form was received by Integra they will send an RMA number, directions to return the product, and input an order to replace the quantity they indicated on the form.\nCustomers with questions were instructed to call 1-855-532-1723.\nFor questions regarding this recall call 855-532-1723.", "product_quantity": "78 packages", "distribution_pattern": "Worldwide Distribution - USA including FL, NE, WI, WA, CT, ND, AL, NY, NH, OR, OK, MN, and TX. Internationally to Belgium, Czech Republic, Germany, France, Great Britian, Italy, Poland, and Portugal.", "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", "K200807", "K971511", "K792005", "K024040", "K981246", "K113526", "K913636", "K083076", "K853363", "K233448", "K874508", "K871752", "K021196", "K181902", "K831678", "K925810", "K800168", "K853361", "K820311", "K864676", "K914995", "K171880", "K834593", "K760501", "K853366", "K934545", "K063836", "K030081", "K790849", "K974096", "K891456", "K161605", "K970658", "K823509", 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"K172537", "K990256", "K861961", "K903844", "K951258", "K921936", "K030698", "K040943", "K192289", "K030289", "K820312", "K980778", "K922936", "K935560", "K002970", "K110751", "K955265", "K853369", "K033704", "K082127", "K110560", "K030468", "K053107", "K843132", "K181622", "K910938", "K032817", "K050739", "K122118", "K190174", "K170599", "K221840", "K981046", "K811288", "K081942", "K944595", "K883114", "K904883", "K971799", "K092395", "K171586", "K013488", "K871685", "K992173", "K141687", "K790126", "K251598", "K123524", "K152152", "K200950", "K760784", "K905860", "K041296", "K091328", "K102961", "K892215", "K042825", "K854474", "K243531", "K081773", "K212641", "K954285", "K974726", "K884036", "K911410", "K143111", "K853215", "K031097", "K152700", "K913412", "K090348", "K853371", "K962097", "K172022", "K000057", "K152897", "K024101", "K932429", "K971617", "K911433", "K140722", "K931989", "K243552", "K123554", "K062009", "K781768", "K984053", "K972994", "K853362", "K172759" ], 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"medical_specialty_description": "Neurology", "regulation_number": "882.5550", "device_class": "2" } } ] }