{ "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": "204169", "product_res_number": "Z-0492-2024", "event_date_initiated": "2023-10-19", "event_date_posted": "2023-12-06", "recall_status": "Open, Classified", "res_event_number": "93356", "product_code": "HBG", "k_numbers": [ "K961113" ], "product_description": "Integra Cranial Access Kit\t-For access to the subarachnoid space or the lateral ventricles of the brain.\t\nCatalog Number: INS7270", "code_info": "UDI-DI: 10381780431930\t\nLot Number/Exp. Date: \n6824670\t1-Aug-24\t\n7127164\t1-Sep-24", "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": "Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the sterility of the device", "root_cause_description": "Process control", "action": "Integra notified consignees (Hospitals, Government facilities, and Distributors) via \nFedex priority overnight on 10/19/23 . Letter titled: 1st Notification- Urgent: Voluntary Medical Device Recall. Letter states reason for recall, health risk and action to take:\n\nActions to be Taken by Customers:\n1. If you do have units of the affected product listed in Table 1, remove it immediately from service.\n2. If you do have affected product, check the box on the enclosed form I do have affected product. Record the total quantity of the affected product that you have.\n3. If you do not have affected product, check the box, I do not have affected product. \n4. Complete the attached Acknowledgement Form and return to FCA2@integralife.com or FAX to 1-609-750-4220.\n5. Keep a copy of the form for your records.\n6. When your form is received, and it is noted that you have affected product, Customer Service will contact you and provide a Return Material Authorization (RMA) number and directions to return the affected product. You can request a credit or a replacement for the quantities returned (based on inventory availability).\nActions to be Taken by Distributors/Sales Reps:\n1. If you do have the affected product listed in Table 1, remove the product from further distribution.\n2. Complete the attached acknowledgment form.\n3. If you do have affected product, check the box I do have affected product . Record the total quantity of affected product you have.\n4. After completion, please email the Acknowledgement Form to FCA2@integralife.com or FAX to 1-609-750-4220.\n5. Keep a copy of the form for your records.\n6. Please check your customer traceability records for shipments of above catalog and lot numbers.\n7. Forward a copy of the enclosed Field Safety Notice to any of your customers that have purchased the above catalog and lot number.\n8. When the form from you and your customer is received, and it is noted that you or your customer has affected product, Customer Service will c", "product_quantity": "173 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Argentina, Australia, \nBelgium, Canada, Chile, France, Ireland, Israel, South Africa, United Kingdom.", "openfda": { "k_number": [ "K022370", "K162884", "K892531", "K153587", "K902818", "K862160", "K932402", "K160129", "K904283", "K022712", "K874952", "K915546", "K122456", "K875018", "K151536", "K961113", "K252696" ], "registration_number": [ "3003080184", "3014334038", "3018094310", "3006554912", "1043653", "8010405", "8010168", "2029275", "3012507533", "3010041511", "2031093", "9611274", "8010303", "1220477", "3004215117", "8040179", "1836161", "3015399803", "9611112", "8040233", "3009865268", "3015531529", "3013557562", "3016577622", "8010769", "3011137372", "1423714", "3023852420", "1721676", "8030607", "3008102049", "3008812560", "3003418325", "3034676720", "2031917", "1319639", "3003730855", "3011689956", "9680515", "1923569", "2023988", "3028006458", "3004608878", "9614945", "1417592", "8010300", "3007773213", "1722447", "3009417901", "3008868758", "2011171", "3005809810", "2183456", "2183319", "9710524", "8044098", "3005067367" ], "fei_number": [ "3003080184", "3014334038", "3018094310", "3006554912", "1043653", "3004028763", "3003944071", "3012507533", "3010041511", "1000138054", "1220477", "3004215117", "4439", "7282", "3006509795", "3008782585", "3546", "1000306431", "3015399803", "3002808043", "3002806452", "3009865268", "3015531529", "3013557562", "3016577622", "3001236549", "1000138491", "3005969827", "3023852420", "3002929183", "1721676", "3004207793", "3008102049", "3008812560", "3003418325", "3034676720", "3005747797", "3000719482", "1000453845", "3002750084", "3011689956", "4442", "3003730855", "3008237805", "1923569", "3028006458", "3004608878", "1417592", "3003499455", "3007773213", "3009417901", "3008868758", "2011171", "3005809810", "2183456", "2183319", "2023988" ], "device_name": "Drills, Burrs, Trephines & Accessories (Manual)", "medical_specialty_description": "Neurology", "regulation_number": "882.4300", "device_class": "2" } } ] }