{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "219563", "product_res_number": "Z-1981-2026", "event_date_initiated": "2026-03-19", "event_date_posted": "2026-05-06", "recall_status": "Open, Classified", "res_event_number": "98720", "product_code": "LRO", "product_description": "Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor\n\nCORONARY ANGIO PACK\nModel numbers ANCA80AP\nANCA80AQ", "code_info": "ANCA80AP\nUDI-DI 191072232168\nLot 42-8146111\n\nANCA80AQ\nUDI-DI 191072236678\nLots\n\n42-8207211\n42-8267711\n42-8311311\n42-8337611\n42-8353311\n42-8379211\n42-8407111\n42-8510711\n42-8575111\n42-8611511\n42-8718911\n42-8718912\n42-8722611\n42-8805311\n42-8820611\n42-8870911", "firm_fei_number": "3008492337", "recalling_firm": "American Contract Systems Inc", "address_1": "85 Shaffer Park Dr", "city": "Tiffin", "state": "OH", "postal_code": "44883-9290", "additional_info_contact": "Marlene Jones\n419-455-2090", "reason_for_recall": "Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and manifold. Potential risk for biohazard exposure, blood loss, infection, or air embolism.", "root_cause_description": "Nonconforming Material/Component", "action": "Firm notified distributors with an \"URGENT: MEDICAL DEVICE RECALL NOTIFICATION\" dated March 19, 2026, via email. Distributors were instructed to notify end-users. An updated letter with additional kits was sent to the customer on 3/20/26.\n\nCustomers should quarantine all affected product. Customers may add warning labels to affected ACS kits to ensure all users are aware of prescribed actions that were identified in the Medline recall notice. The warning labels state,\n\n\"Per Medline, due to the risk of serious injury or death, customers are directed to remove and destroy all Namic RA Syringes. If use is unavoidable because failure to proceed would result in patient harm, the Namic RA syringe must be used with extreme caution and vigilance, including manual stabilization of syringe-to-manifold connections and continuous, 100% monitoring during setup and throughout the entire procedure.\"\n\nCustomers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have.\n\nIf you have any questions, contact the Regulatory Affairs Manager, by email: gm-omra_recalls@owens-minor.com or at 419-455-2090.", "product_quantity": "7,311 kits", "distribution_pattern": "US distribution to MN. No OUS distribution.", "openfda": { "k_number": [ "K882684", "K936117", "K964921", "K872448", "K910368", "K920267", "K931820", "K935686", "K874760", "K842648", "K965201", "K041080", "K952539", "K961683", "K971062", "K903336", "K913136", "K951149", "K854095", "K935743", "K925216", "K962826", "K925016", "K920292", "K963715", "K905004", "K933137", "K944044", "K901856", "K893814", "K923600", "K925467", "K961863", "K871437", "K023276", "K872011", "K924468", "K971061", "K890570", "K950574", "K930270", "K914935", "K902887", "K963443", "K871459", "K945831", "K931824", "K880942", "K945481", "K964011", "K934028", "K931760", "K902293", "K871322", "K930700", "K890726", "K892389", "K873973", "K970286", "K854292", "K932220", "K902888", "K932221", "K963721", "K910365", "K934688", "K030721", "K881083", "K934029", "K931844", "K871434", "K883250", "K931673", "K950295", "K945160", "K951478", "K914037", "K894685", "K926269", "K980137", "K970187", "K871873", "K935858", "K880961", "K884093", "K925214", 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