{ "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": 1 } }, "results": [ { "cfres_id": "209952", "product_res_number": "Z-0027-2025", "event_date_initiated": "2024-08-16", "event_date_posted": "2024-10-08", "recall_status": "Open, Classified", "res_event_number": "95306", "product_code": "LRO", "product_description": "Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes.\n\nProduct packaged in a convenient manner for use in a general clinical procedure.", "code_info": "Catalog Number: AMS9300A\nUDI-DI code: B098AMS9300A0\nLot Numbers:\n168030\n171362\n172981\n177913\n179608\n181537\n185126\n189873\n189874\n196460\n196461\n198850\n200902\n206846\n208255\n209391", "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\n406-373-7438", "reason_for_recall": "Due to convenience kits containing a kit component that is under a recall action for improper use.", "root_cause_description": "Use error", "action": "On 08/16/2024, the firm email an \"URGENT: MEDICAL DEVICE PRODUCT CORRECTION\" Letter to customers informing them that Cardinal Health is conducting a product correction for its Salem Sump PVC Tubes. These Sump PVC tubes were included in the Aligned Medical convenience kits. The correction for this Recall is an updated product label, an electronic instruction for use (eIFU). The updated labeling is to address improper use of the Sump PVC tubes which can lead to breakage of the Salem Sump Anti Reflux Valve (ARV) that increases risk to patients.\n\nCustomers are instructed to:\n1.\tReview your inventory for the affected kits, all lots are impacted\n2.\tCommunicate the change to the use instructions with all personnel that utilize Salem Sump\" products contained within AMS kits.\n3.\tIf you have further distributed this product, please identify your distribution partners, and notify them at once of the product correction. Your notification to your customers should include a copy of this notification letter. \n4.\tPlease complete and return the AMS Urgent Medical Device Product Correction Response Required form within 5 business days and return via email to fieldcorrectiveaction@alignedmedical.com even if you have no affected product on hand.\n\nFor questions or concerns, contact Aligned Medical Solutions at fieldcorrectiveaction@alignedmedicalsolutions.com", "product_quantity": "642 kits", "distribution_pattern": "U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.", "openfda": { "k_number": [ "K881083", "K903336", "K971062", "K941846", "K925467", "K931758", "K962826", "K932652", "K950295", "K874760", "K873973", "K902888", "K910365", "K924468", "K854095", "K964921", "K931820", "K902887", "K953083", "K871873", "K882684", "K951149", "K890729", "K030721", "K936117", "K041080", "K854292", "K945831", "K902293", "K970187", "K935483", "K944044", "K935743", "K890098", "K964011", "K922648", 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