{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "214769", "product_res_number": "Z-2129-2025", "event_date_initiated": "2025-07-11", "event_date_posted": "2025-08-06", "recall_status": "Open, Classified", "res_event_number": "97186", "product_code": "FRN", "k_numbers": [ "K223607" ], "product_description": "Plum Duo Infusion System, List Number: 400020401", "code_info": "UDI-DI: M335400021;\nSerial Numbers: 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"firm_fei_number": "3013319212", "recalling_firm": "ICU Medical, Inc.", "address_1": "600 N Field Dr", "city": "Lake Forest", "state": "IL", "postal_code": "60045-4835", "reason_for_recall": "ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.", "root_cause_description": "Under Investigation by firm", "action": "An \"URGENT: MEDICAL DEVICE CORRECTION\" notification letter dated 7/11/25 was sent to customers. The letter described the product, problem and actions to be taken.\n\nActions for Users:\n1. Identify all affected infusion pumps in your possession and ensure all users or potential users of these pumps are immediately made aware of this notification.\n2. To stop an infusion, ensure that users carefully attend to the \"CONFIRM STOP\" message that appears after pressing the STOP button. The \"CONFIRM STOP\" message includes a yes/no selection to confirm the intent to stop the infusion, thereby helping to prevent unintended interruptions.\n3. If the pump becomes unresponsive, exchange the pump and reprogram.\nFollow-up Actions by ICU Medical:\nICU Medical will develop a patch to correct this issue for Plum Duo.\nICU Medical will contact you to schedule the software update for your pumps if needed.\n\nhttps://icumed.custhelp.com/app/market-action\nFor any questions regarding this action\n\nTechnical Support\n1-(800)-241-4002, option 3\ntsc.support@icumed.com", "product_quantity": "4677 units", "distribution_pattern": "US Nationwide.", "openfda": { "k_number": [ "K800627", "K904923", "K834461", "K823406", "K955258", "K830017", "K230022", "K030459", "K832289", "K230083", "K993524", "K905783", "K002679", "K880479", "K863683", "K832923", "K052217", "K840263", "K801725", "K842421", "K904403", "K790373", "K024190", "K841018", "K812035", "K803190", "K841827", "K813455", "K902891", "K875332", "K983005", "K080743", "K003582", "K980378", "K820219", "K872514", "K003611", "K031749", "K921073", "K843548", "K861207", "K950419", "K093332", 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