{ "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": "160958", "product_res_number": "Z-0682-2018", "event_date_initiated": "2017-07-24", "event_date_created": "2018-02-21", "recall_status": "Terminated", "event_date_terminated": "2019-11-07", "res_event_number": "78951", "product_code": "FMG", "k_numbers": [ "K012157" ], "product_description": "3-Way Standardbore Stopcock. Product Code: AMS-100.", "code_info": "Lot Number: 1706064D", "firm_fei_number": "1000120555", "recalling_firm": "Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.", "address_1": "87 Venture Dr", "city": "Dover", "state": "NH", "postal_code": "03820-5914", "reason_for_recall": "Vygon is conducting a voluntary recall of the products and lots listed in this recall, being\ninitiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the\nTyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging.\nThis potential lack of adhesive may affect the sterility of the product.", "root_cause_description": "Under Investigation by firm", "action": "Vygon sent recall letters dated July 24, 2017, to customers via email and fax with read receipts and delivery confirmations. The recall letter informed customers of the reason for recall, product description, code and lot number, and instructions to customers, with a Recall Acknowledgement and Inventory Return Form provided/accompanying the recall letter.", "product_quantity": "200 units", "distribution_pattern": "U.S.", "openfda": { "k_number": [ "K800862", "K052330", "K760678", "K932512", "K041779", "K790010", "K022895", "K792126", "K810375", "K853275", "K884435", "K823120", "K061143", "K940070", "K760666", "K082836", "K800863", "K851986", "K760679", "K771911", "K872067", "K864900", "K884463", "K954984", "K820165", "K242255", "K800864", "K010217", "K812927", "K842173", "K760667", "K770707", "K881805", "K782167", "K961982", "K082106", "K053405", "K962581", "K223175", "K854348", "K891234", "K870261", "K954970", "K211204", "K840394", "K792128", "K012157", "K862691", "K071400", "K800284", "K792124", "K782168", "K080077", "K982368", "K770708", "K974083", "K860889", "K780662", "K830198", "K870324", "K060231", "K964435", "K792127", "K911415", "K913560", "K210516", "K953573", "K130245", "K955782", "K792125", "K862492", "K823469", "K223499", "K850280", "K123084", "K172266", "K902724", "K872066", "K190489", "K070143", "K082110", "K190539", "K141254", "K823373", "K864440", "K802258", "K770916", "K032393", "K780596" ], "registration_number": [ "3010432890", "1060680", "1649914", "3020778", "3006891665", "2029275", "1416980", "1423507", "3007017524", "1713468", "1047429", "1423662", "1047843", "2025816", "1000563940", "3006950086", "3012261967", "9610849", "1625425", "3007344957", "3015276780", "1223004", "9612052", "2011171", "3012798826", "1644312", "2032112", "2245270", "3004111573", "3003704957", "3015309643", "2523676", "3007738736", "9616088", "2024024", "1220477", "1018470", "3010041511", "1518293", "3017636737", "3005941719", "9610847", "3013517171", "9615817", "3045322464", "3010421104", "3009211636", "8020616", "3006475220", "9612152", "3002907620", "3012809732", "3032916632", "1423537", "1043214", "8040700", "9617594", "1424263", "3015173212", "1061124", "3013557562", "9614279", "3030447506", "2243072", "3013188547", "1055236", "2032098", "3033589330", "3012536737", "3015085713", "3013683058", "1030451", "1526863", "9616567", "3013764800", "2022435", "9613418", "1928237", "1319639", "3035642068", "3033536319", "9680794", "1054241", "3005012805", "2320762", "3006425876", "3012410077" ], "fei_number": [ "3010432890", "1000138054", "3002902735", "3020778", "3001236905", "3006891665", "1416980", "1000208624", "3007017524", "1713468", "1047429", "3003040625", "1047843", "2025816", "3002807391", "1000563940", "3006950086", "3012261967", "3002807111", "1625425", "3007344957", "3015276780", "3002879021", "2011171", "3003076831", "3012798826", "1000120555", "2245270", "1000306431", "3003081151", "3002806588", "3004111573", "3003704957", "3015309643", "2523676", "3007738736", "3001044237", "2024024", "1220477", "1018470", "3010041511", "3003058448", "3002806476", "1518293", "3017636737", "3008002452", "3013517171", "3045322464", "3010421104", "3009211636", "3001665800", "3006475220", "3002907620", "3012809732", "3032916632", "3002806443", "1043214", "1000112968", "3002963732", "3003737899", "1000512168", "3000215273", "3015173212", "3013557562", "3030447506", "2243072", "1000117748", "3013188547", "1000112877", "3002806901", "3033589330", "3012536737", "3015085713", "3013683058", "1030451", "1526863", "3013764800", "2022435", "3003015552", "1928237", "3003767881", "3035642068", "3033536319", "3005012805", "3006425876", "3003807466", "3012410077" ], "device_name": "Stopcock, I.V. Set", "medical_specialty_description": "General Hospital", "regulation_number": "880.5440", "device_class": "2" } } ] }