{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "113590", "product_res_number": "Z-0078-2013", "event_date_initiated": "2012-09-25", "event_date_posted": "2012-10-18", "recall_status": "Terminated", "event_date_terminated": "2012-11-08", "res_event_number": "63365", "product_code": "FZP", "k_numbers": [ "K993157" ], "product_description": "Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Teleflex Medical, Research Triangle Park, NC 27709.\n\nTeleflex Medicals Hem-o-lok polymer ligating clips are single use, sterile, non-absorbable medial devices that have been designed to ligate vessels and tissue structures during various types of surgical procedures. Vessels and tissue structures in the range of 0.5 to 16 mm can be effectively ligated with Hem-o-lok clips.", "code_info": "Catalog No. 544240, Lot #01E1200585", "firm_fei_number": "3005747797", "recalling_firm": "Teleflex Medical", "address_1": "2917 Weck Dr.", "city": "Research Triangle Park", "state": "NC", "postal_code": "27709", "additional_info_contact": "Michael T. Taggart\n919-433-4940", "reason_for_recall": "Product is being recalled due to the possibility that the tray may contain pinholes, compromising product sterility.", "root_cause_description": "Packaging process control", "action": "Teleflex sent a Urgent Medical Device Recall Notification dated September 25, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.\n\nCustomers were instructed to check their inventory and quarantine any affected inventory found. They were to complete the enclosed Field Corrective Action Acknowledgement Form and return it to the Teleflex Medical sales representative who will then remove the affected product from the facility and ensure its return to Teleflex Medical.\n\nWe sincerely apologize for any inconvenience this action may cause your operations. If you have any questions please contact your local sales representative or Customer Service at 1-866-246-6990.", "product_quantity": "126 units", "distribution_pattern": "Nationwide Distribution including the state of Nevada.", "openfda": { "k_number": [ "K020470", "K250643", "K200166", "K971588", "K982944", "K853650", "K142869", "K090872", "K121194", "K864102", "K971201", "K032980", "K052018", "K062914", "K143598", "K062008", "K843336", "K013264", "K081225", "K254231", "K000278", "K053524", "K981631", "K050356", "K032896", "K073123", "K864350", "K964470", "K012317", "K024366", "K830503", "K012342", "K091987", "K180010", "K132658", "K993135", "K040602", "K030269", "K102081", "K221495", "K993424", "K110699", "K962043", "K861922", "K173031", "K163261", "K033161", "K033324", "K801124", "K841548", "K862404", "K032217", "K841549", "K122276", "K172742", "K161758", "K251054", "K982941", "K093679", "K040832", "K900122", "K213813", "K142120", "K850273", "K020054", "K843589", "K954435", 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