{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "124276", "product_res_number": "Z-0551-2014", "event_date_initiated": "2013-11-26", "event_date_posted": "2013-12-20", "recall_status": "Terminated", "event_date_terminated": "2014-04-09", "res_event_number": "66949", "product_code": "JXG", "k_numbers": [ "K042359" ], "product_description": "Integra Cranial Access Kit, Model Number HITHSP10, Rx Only.\r\nIntegra Cranial Access Kits (CRAK) allows for burr hole access to the subarachnoid space or the lateral ventricles of the brain. The kit is intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of Cerebrospinal Fluid (CSF), and to monitor ICP. These kits contain all components and accessories required for burr hole access into the cranium.", "code_info": "Lot No. W1302120 Expires 2/1/2014  Lot No. W1305038 Expires 8/1/2015  Lot No. W1306137 Expires 9/1/2014", "firm_fei_number": "1000138491", "recalling_firm": "Integra LifeSciences Corp. d.b.a. Integra Pain Management", "address_1": "3498 West 2400 South #1050 3498 West 2400 South", "address_2": "#1050", "city": "Salt Lake City", "state": "UT", "postal_code": "84119", "additional_info_contact": "Mr. David E. Gronostajski\n609-936-6822", "reason_for_recall": "Integra LifeSciences is voluntarily recalling any\r\nunexpired lots of HITHSP10 Cranial Access Kits due to identified labeling discrepancies. kit contains DuraPrep and Monocryl sutures whose labeling does not align with the intended use and labeling of the Cranial Access Kit.", "root_cause_description": "Labeling mix-ups", "action": "Integra sent an Urgent Voluntary Medical Device Recall letter dated November 26, 2013, to all affected consignees. The letter identified the product, the problem, the action to be taken by the consignee and included a Recall Acknowledgement and Return form. Consignees were instructed to review their inventory and determine if they have any affected product, stop using the affected product immediately and remove from service. Consignees were instructed to complete the attached form even if they do not have the affected product in their inventory and return by email or fax as indicated on the form. \r\nWhen the form is received Customer Service will send an RMA number and directions to return the product. Customers with questions were instructed to contact Customer Service at 1-855-532-1723 or their Integra sales representative at 909-201-4099.\r\nFor questions regarding this recall call 609-936-6822.", "product_quantity": "731", "distribution_pattern": "Nationwide Distribution", "openfda": { "k_number": [ "K984583", "K120559", "K931989", "K081773", "K030081", "K963802", "K974708", "K854474", "K091328", "K984053", "K223330", "K944222", "K003564", "K902257", "K212641", "K854049", "K012052", "K021653", "K122118", "K252514", "K913636", "K200950", "K222471", "K911433", "K090342", "K920156", "K944595", "K233448", "K042359", "K102961", "K921936", "K050739", "K011030", "K902783", "K121248", "K171880", "K973525", "K024101", "K243531", "K903844", "K042465", "K873247", "K033850", "K862303", "K250636", "K870660", "K110206", "K924600", "K971617", "K855058", "K853363", "K981046", "K042481", "K162437", "K140722", "K243552", "K862907", "K964386", "K992465", "K955265", "K980903", "K040943", "K073139", 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