{ "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": "184975", "product_res_number": "Z-0724-2021", "event_date_initiated": "2020-12-14", "event_date_created": "2020-12-23", "recall_status": "Terminated", "event_date_terminated": "2021-07-19", "res_event_number": "86986", "product_code": "JXG", "k_numbers": [ "K172022" ], "product_description": "Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting cerebrospinal fluid (CSF)\n\nPart Number: 823073", "code_info": "Lot Number: 4178253 Exp. Date: November 2019", "firm_fei_number": "3003418325", "recalling_firm": "Integra LifeSciences Corp.", "address_1": "1100 Campus Rd", "city": "Princeton", "state": "NJ", "postal_code": "08540-6650", "additional_info_contact": "Lacey Gigante\n609-212-9004", "reason_for_recall": "Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa", "root_cause_description": "Labeling Change Control", "action": "Integra Lifesciences notified consignees (Hospitals and Sales Representatives ) by Urgent Medical Device Recall letter between December 14 and 16, 2020 via courier service, facsimile or email about the initial notification between December 14 and 16, 2020. Letter state reason for recall, health risk and action to take:\nCustomers\na. If you do have the affected product in Table 1, remove the product from service.\nb. Complete the attached acknowledgement form. If you do have affected product, check the box I do\nhave affected product. Record the total quantity of the affected product you have.\nc. If you do not have affected product, check the box, I do not have affected product.\nd. Return the completed acknowledgement form to FCA2@integralife.com\nor FAX to 1-609-750-4220\ne. Keep a copy of the form for your records.\nf. When your form is received, and it is noted that you have the affected product, Customer Service will contact you and provide a Return Material Authorization (RMA) number and directions to return the product. A replacement order will also be placed for the quantity noted on the form.\n\nQuestions regarding these instructions, please contact Customer Service:\nUSA: 800-654-2873\nMonday- Friday 8:00AM EST 6:00PM EST\ncustsvcnj@integralife.com", "product_quantity": "85 units", "distribution_pattern": "US Nationwide distribution.", "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", 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"3004530184", "3024673", "3044156918", "3008791915", "2011171", "3043513133", "3014507028", "2023988" ], "device_name": "Shunt, Central Nervous System And Components", "medical_specialty_description": "Neurology", "regulation_number": "882.5550", "device_class": "2" } } ] }