{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "219675", "product_res_number": "Z-2066-2026", "event_date_initiated": "2026-04-02", "event_date_posted": "2026-05-08", "recall_status": "Open, Classified", "res_event_number": "98741", "product_code": "LRO", "product_description": "Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes)\n\nAngio Pack\nPart numbers AMS6908E, AMS6908F", "code_info": "Pack AMS6908E\nUDI-DI B098AMS6908E0\nLot 214875\n\nPack AMS6908F\nUDI-DI B098AMS6908F0\nLots 215436, 225001, 226706, 234088", "firm_fei_number": "1000125955", "recalling_firm": "Windstone Medical Packaging, Inc.", "address_1": "1602 4th Ave N", "city": "Billings", "state": "MT", "postal_code": "59101-1521", "additional_info_contact": "Jeff Jensen\n406-671-9324", "reason_for_recall": "Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection between syringe and manifold. If unwinding occurs, there is a potential for biohazard exposure, blood loss, infection. or air embolism.", "root_cause_description": "Device Design", "action": "Firm began notifying consignees via email on April 2, 2026. Notice was titled \"URGENT: MEDICAL DEVICE RECALL.\"\n\nConsignees were instructed to check inventory and quarantine affected products. Firm instructed consignees to over-label affected products with a sticker which states that at the time the kit is opened, the affected Medline syringe should be identified and set aside, and that the affected syringe should be rendered unusable and disposed of. Firm will provide labels for any kits that need to be identified.", "product_quantity": "150 kits (US only)", "distribution_pattern": "US Nationwide distribution in the state of Arizona.", "openfda": { "k_number": [ "K970187", "K871434", "K890570", "K902887", "K935741", "K935740", "K023276", "K931758", "K980137", "K950574", "K945831", "K872448", "K890726", "K872011", "K914037", "K914036", "K920267", "K932221", "K924468", "K895202", "K931760", "K951149", "K961863", "K920292", "K854292", "K934428", "K874439", "K910365", "K963443", "K913136", "K890729", "K934028", "K854095", "K881083", "K871459", "K871322", "K905004", "K894685", "K935483", "K971061", "K935686", "K041080", "K964921", "K885090", "K213481", "K892389", "K925467", "K944044", "K970286", "K212258", "K963715", "K905459", "K951478", "K931824", "K902293", "K925016", "K922648", "K903336", "K934029", "K961683", "K931844", "K930700", "K871873", "K932652", "K030721", "K925214", "K932217", "K880942", "K971062", "K930270", "K874760", 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"1921846", "3002806603", "3041276890", "3017467279", "3011270181", "3013600605", "3045816907", "3042158935", "3005669815", "3023140882", "3011532690", "3010166880", "3011545608", "3011144486", "8030672", "1417592", "3005246893", "3045857302", "3042480961", "1824619", "2320762", "3004111573", "3011554160", "1055892", "3007344957", "3008824097", "3035642068", "2029275", "3005997949", "1422634", "3015173212", "3007007790", "3036002406", "1055954", "3008403546", "3005595283", "3018116884", "3009750712", "1047429", "3010376936", "3019798849", "2011171" ], "fei_number": [ "3009203853", "3013735189", "3006191977", "1000208624", "3009888344", "3014325891", "3013421458", "3009637528", "3004122598", "3005012805", "3014704068", "1000112877", "3000718854", "2936485", "3008496560", "3006450239", "1527607", "1000111202", "3012811961", "3007829657", "3003924117", "3017430544", "3003803331", "3010878085", "3027977504", "3011494917", "1721686", "3003495693", "3043620414", "3010305275", "3010452421", 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