{ "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": "155010", "product_res_number": "Z-2120-2017", "event_date_initiated": "2017-04-25", "event_date_posted": "2017-05-19", "recall_status": "Terminated", "event_date_terminated": "2017-08-21", "res_event_number": "77132", "product_code": "KMK", "product_description": "StatLock IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film pouches, the product is distributed in cartons containing 25 devices and cases containing 250 devices.", "code_info": "Lot Number JUAQF675, Exp 2/28/2019", "firm_fei_number": "3006260740", "recalling_firm": "Bard Access Systems Inc.", "address_1": "605 N 5600 W", "city": "Salt Lake City", "state": "UT", "postal_code": "84116-3738", "reason_for_recall": "StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip.", "root_cause_description": "Process control", "action": "Bard Access sent an Urgent: Product Recall letter dated May 15, 2017, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.\n\nPlease immediately examine your inventory and quarantine any product subject to this notification. Please complete and return the enclosed response form as soon as possible. Bard Access Systems will provide instructions for returning impacted product for credit or replacement upon receipt of the response form.\n\nIf you have further distributed this product, please identify your customers and inform them of this notification at once. You may include a copy of this letter in your notification to your customers.\n\nPlease direct all return requests or other questions to our coordinator for credit or replacement product at 1-800-290-1689.\n\nWe sincerely regret any inconvenience this may cause to you or your facility.\n\nFor further questions, please call (801) 522-5000.", "product_quantity": "4,500 units", "distribution_pattern": "Nationwide Distribution - Internationally to Canada. \n No govt/VA/Military consignees.", "openfda": { "k_number": [ "K925992", "K841487", "K854040", "K800024", "K930197", "K873311", "K850503", "K911070", "K900134", "K912942", "K924566", "K924249", "K912660", "K842999", "K860071", "K832300", "K963365", "K810579", "K770119", "K822732", "K821317", "K910880", "K943147", "K781800", "K924180", "K870770", "K895993", "K853418", "K896421", "K864190", "K821796", "K941940", "K935389", "K930663", "K922103", "K941850", "K821957", "K932757", "K800726", "K812080", "K925502", "K860706", "K792049", 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