{ "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": "204708", "product_res_number": "Z-0635-2024", "event_date_initiated": "2023-11-28", "event_date_posted": "2024-01-04", "recall_status": "Open, Classified", "res_event_number": "93550", "product_code": "JXG", "k_numbers": [ "K162437" ], "product_description": "EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only", "code_info": "UDI: 00382830050555/ Lot #: 1FX0004588937\t1FX0004588938\t1FX0004588939\t1FX0004663828\t1FX0004663825\t1FX0004663826\t1FX0004663824\t1FX0004663827\t1FX0004857869\t1FX0004857871\t1FX0004663829\t1FX0004663830\t1FX0004857870\t1FX0004763454\t1FX0004833126\t1FX0004833140\t1FX0004833139\t1FX0004857872\t1FX0004857873\t1FX0004833127\t1FX0004833136\t1FX0004763455\t1FX0004763460\t1FX0004763463\t1FX0004763464\t1FX0004763462\t1FX0004763461\t1FX0004763459\t1FX0004857877\t1FX0004857875\t1FX0004857874\t1FX0004763457\t1FX0004857876\t1FX0004763465\t1FX0004763456\t1FX0004833141\t1FX0004763458\t1FX0004857882\t1FX0004857881\t1FX0004857880\t1FX0004857878\t1FX0004857879\t1FX0004857886\t1FX0004857884\t1FX0004857885\t1FX0004857887\t1FX0004857888\t1FX0004857886\t1FX0004857883\t1FX0004857889", "firm_fei_number": "2023988", "recalling_firm": "Natus Medical Incorporated", "address_1": "5955 Pacific Center Blvd", "city": "San Diego", "state": "CA", "postal_code": "92121-4309", "additional_info_contact": "sr. Quality Specialist\n858-455-1115", "reason_for_recall": "Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.", "root_cause_description": "Process change control", "action": "On November 28, 2023, Natus issued a \"Urgent Medical Device Recall\" Notification to affected consignees via USPS. Natus asked consignees to take the following actions: \n\n1. Immediately cease use of the affected System and quarantine any inventory until you receive the shipping instructions from Natus to return any System(s).\n\n2) Please complete the enclosed form and return to FCA@Natus.com. You will receive shipping instructions from FCA@Natus.com\n\n3) Adverse reactions or quality problems experienced with the use of the System should be reported to Natus and the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.\n\" Complete and submit the report Online at www.fda.gov/medwatch/report.htm\n\" Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178\n\n4) Replacement System(s) will be made available to you at no cost. Natus Technical Service will be in contact with you shortly to arrange for the provision of replacement System(s).", "product_quantity": "3,336 units", "distribution_pattern": "US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, \tIL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV.", "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", 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