{ "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": "167392", "product_res_number": "Z-0120-2019", "event_date_initiated": "2018-08-10", "event_date_created": "2018-10-16", "recall_status": "Terminated", "event_date_terminated": "2021-05-13", "res_event_number": "81076", "product_code": "BYX", "product_description": "Disposable Smooth Interior Tubing\nMaterial: Polyethylene EVA copolymer.\nThis tubing is supplied non-sterile\nP/N: 1024920 Rev. 01\n\n Low temperature smooth interior tubing is a disposable pulmonary equipment interconnect used in ventilation and aesthesia machines.", "code_info": "Product Code: 243301 Lot Numbers: 572015 574717 578973 579100 582567", "firm_fei_number": "3020614", "recalling_firm": "A M Systems Inc", "address_1": "131 Business Park Loop", "address_2": "Box 850", "city": "Sequim", "state": "WA", "postal_code": "98382-8338", "additional_info_contact": "Robert Thompson\n360-683-8300 Ext. 1302", "reason_for_recall": "Some of the Disposable Smooth Interior Tubing may pull apart when stretched.", "root_cause_description": "Process control", "action": "On 08/10/2018, the firm, A-M Systems, sent an \"URGENT: Notification of Product Recall/Correction\" letter to customers via email informing them that it was determined that some of the Disposable Smooth Interior Tubing may pull apart when stretched. Customers were advised to provide the firm with the number of items distributed from the affected lots and the number of items still remaining in their inventory from these lots so that the firm could accurately track the status of this correction action. The customers are instructed to please use the enclosed form and self-addressed envelope to return the information to the firm immediately. Once the customers have provided the firm with an accurate count of items distributed and items remaining in the customer's control please destroy or discard any remaining product in your possession from these lot numbers.\n\nIf you have any questions, please contact Quality Manager at Tel: 360.683.8300 x1302 or Email: rthompson@a-msystems.com.", "product_quantity": "610", "distribution_pattern": "US Distribution to states of: OH, PA, and NC.", "openfda": { "k_number": [ "K904701", "K811549", "K901983", "K813197", "K905091", "K781231", "K854239", "K931033", "K860877", "K904757", "K790160", "K823142", "K801261", "K810362", "K852081", "K801260", "K853569", "K931043", "K935835", "K811550", "K943110", "K913422", "K841901", "K810344", "K760220", "K813074", "K800509", "K904702", "K011134", "K781428", "K810374", "K901961", "K771075", "K905094", "K790150", "K801514", "K863912", "K801190", "K831082", "K791821", "K840790", "K790159", "K802071", "K904337", "K914980", "K800664", "K790147", 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