{ "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": "109282", "product_res_number": "Z-0759-2013", "event_date_initiated": "2012-04-12", "event_date_posted": "2013-01-31", "recall_status": "Terminated", "event_date_terminated": "2014-04-10", "res_event_number": "61879", "product_code": "JAQ", "k_numbers": [ "K011657" ], "product_description": "Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.", "code_info": "All lots", "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": "Pete Coronado\n434-977-8495", "reason_for_recall": "A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.", "root_cause_description": "Component design/selection", "action": "Varian Medical Systems an an Urgent Medical Device Correction letters dated April 11, 2012 and May 8, 2012 to all affected customers. The April notification advised of an anomaly with titanium rectal retractors, and the correction was expanded in May to include stainless steel retractors. In both notifications, users were instructed to discontinue use and quarantine their cleaned and sterilized devices for collection by Varian field service engineers. Users were requested to return an enclosed reply form to respond with number of units in inventory.", "product_quantity": "344 pieces", "distribution_pattern": "US Nationwide Distribution", "openfda": { "k_number": [ "K093291", "K041929", "K033371", "K171631", "K062241", "K943109", "K864210", "K162499", "K983338", "K020176", "K252884", "K241853", "K020015", "K040704", "K082530", "K980601", "K070574", "K023220", "K031524", "K033828", "K133922", "K142330", "K120344", "K060299", "K130757", "K243045", "K945383", "K781274", "K890799", "K150839", "K881323", "K062830", "K061241", "K052228", "K081179", "K160610", "K080871", "K160815", "K172533", "K082653", "K000081", "K810051", "K120731", "K913908", "K250289", "K952913", "K031158", "K011657", "K923738", "K041715", "K122236", "K141336", "K080565", "K953946", "K961601", "K914578", "K853912", "K902533", "K062823", "K011690", "K130251", "K061582", "K964910", "K172611", "K162615", "K120341", "K071229", "K091230", "K120993", "K915367", "K201279", "K142719", "K091378", "K142597", "K092534", "K912555", "K040541", "K071381", "K082264", "K152018", "K181903", "K060532", "K241965", "K201272", "K262383", "K980576", "K140803", "K162018", "K901615", "K063815", "K001544", "K052595", "K003270", "K240495", "K142986", "K051423", "K191580", "K063382", "K041933", "K122840", "K983115", "K920431", "K221797", "K123941", "K252717", "K132874", "K123912", "K132097", "K031273", "K162533", "K222775", "K891131", "K894381", "K881665", "K990990", "K103215", "K092804", "K172675", "K112420", "K052351", "K032372", "K132889", "K160045", "K981886", "K081079", "K042586", "K955844", "K980590", "K993400", "K832789", "K092405", "K010032", "K250299", "K200221", "K080934", "K232949", "K844714", "K180069", "K063381", "K071467", "K123815", "K901589", "K060349", "K840127", "K242961", "K230155", "K113766", "K183332", "K062824", "K101411", "K070659", "K193240", "K915622", "K142439", "K834308", "K030558", "K141624", "K150979", "K080791", "K141490", "K241386", "K890294", "K091598", "K990753", "K993472", "K922564", "K052947", "K051753", "K030110", "K022739", "K232623", "K233626", "K160021", "K925956", "K251037", "K073133", "K001825", "K954467", "K170203", "K151022", "K062135", "K922554", "K243939", "K983337", "K161576", "K233628", "K042360", "K092323", "K092822", "K061354", "K062826", "K160516", "K151657", "K852842", "K161540", "K241764", "K021286", "K091154", "K022635", "K081677", "K123442", "K111973", "K073107", "K032067", "K161688", "K983341", "K151272", "K983436" ], "registration_number": [ "1000523114", "1650907", "3010813819", "3015232217", "3012536737", "2431392", "3015309643", "3019543601", "3004784537", "2029275", "8010168", "3034286426", "1219183", "1220477", "3014246639", "3003660614", "3000270450", "3032638959", "3007200016", "2022435", "2032338", "3011106828", "3008236846", "1644312", "2021969", "2518443", "3033589330", "1422634", "1417485", "1222780", "9611894", "2184007", "3015225571", "1721504", "9610348", "1181121", "1649518", "1120804", "2032112", "3004111573", "2022694", "3006950086", "3009417901", "3016602874", "3038188187", "2246552" ], "fei_number": [ "1000523114", "1000514656", "3010813819", "3002807741", "3015232217", "3012536737", "2431392", "3015309643", "3019543601", "3004784537", "1219183", "1937223", "1000117748", "1220477", "3014246639", "3003660614", "3000270450", "3032638959", "3007200016", "2022435", "1000115748", "1000306431", "3011106828", "3008236846", "3002681132", "2021969", "2518443", "3033589330", "1417485", "3003076831", "3015225571", "1721504", "3003295907", "1181121", "1000453845", "1120804", "3004111573", "2022694", "3002806617", "3006950086", "1000120743", "3009417901", "3016602874", "3038188187", "2246552", "3001236277" ], "device_name": "System, Applicator, Radionuclide, Remote-Controlled", "medical_specialty_description": "Radiology", "regulation_number": "892.5700", "device_class": "2" } } ] }