{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 124 } }, "results": [ { "cfres_id": "121521", "product_res_number": "Z-0065-2014", "event_date_initiated": "2013-08-09", "event_date_posted": "2013-10-24", "recall_status": "Terminated", "event_date_terminated": "2014-04-10", "res_event_number": "66121", "product_code": "JAQ", "k_numbers": [ "K023220" ], "product_description": "VARISOURCE Breast Template System for high-dose rate Brachytherapy. \n***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer: Varian Medical Systems, Inc., 3100 Hansen Way, Palo Alto, CA 94304 USA", "code_info": "Lots #6078184-1, #6078184-2, #6078184-4", "firm_fei_number": "3000206172", "recalling_firm": "Varian Medical Systems, Inc.", "address_1": "700 Harris St Ste 109 700 Harris St", "address_2": "Ste 109", "city": "Charlottesville", "state": "VA", "postal_code": "22903-4584", "additional_info_contact": "Mark Kattmann\n434-977-8495", "reason_for_recall": "The recall was initiated after Varian Medical became aware the Lexan templates of the Breast Bridge Template System could become bent and turn opaque after steam sterilization.", "root_cause_description": "Nonconforming Material/Component", "action": "Urgent Medical Device Correction, Urgent Field Safety Notice were mailed by FedEx tracked delivery to all consignees on August 12, 2013.", "product_quantity": "3 sets", "distribution_pattern": "Worldwide distribution: US (nationwide) distribution in CA and in the country of India.", "openfda": { "k_number": [ "K022739", "K092822", "K092405", "K232623", "K181903", "K810051", "K062135", "K242961", "K030558", "K080871", "K140803", "K123941", "K172533", "K990990", "K953946", "K062826", "K120993", "K955844", "K240495", "K925956", "K080791", "K781274", "K032372", 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