{ "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": "217676", "product_res_number": "Z-1094-2026", "event_date_initiated": "2025-12-15", "event_date_posted": "2026-01-15", "recall_status": "Open, Classified", "res_event_number": "98129", "product_code": "FRN", "k_numbers": [ "K223607" ], "product_description": "Plum Duo Infusion System, List Number 40002-04-01", "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 received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback for touchscreen inputs.", "root_cause_description": "Nonconforming Material/Component", "action": "An URGENT: MEDICAL DEVICE CORRECTION dated 12/15/25 was sent to customers.\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 informed of this notice. If the devices are used at another location, please ensure this communication is delivered to that location.\n2. If the primary speaker fails, obtain another pump to continue the infusion. Remove the affected pump from clinical use until the speaker can be replaced.\n3. Complete and return the attached Customer Response Form to icumedmarketactionsteam@icumed.com within 10 days of receipt to acknowledge your understanding of this notification.\n4. If you have distributed affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to icumedmarketactionsteam@icumed.com.\n\nFollow-up Actions by ICU Medical:\nICU Medical will address the issue described in this letter through a software update. This update will ensure the backup buzzer will always generate audio for alarms, malfunctions and alerts. ICU Medical will contact you to schedule the software correction for this issue.\n\nDevice Correction Inquiries\nhttps://icumed.custhelp.com/app/market-action\nFor any questions regarding this action", "product_quantity": "423 units", "distribution_pattern": "Worldwide - US Nationwide distribution.", "openfda": { "k_number": [ "K910523", "K052171", "K791293", "K920773", "K842263", "K980092", "K811238", "K031749", "K992044", "K803190", "K833983", "K850669", "K863683", "K894292", "K023264", "K853584", "K870279", "K832923", "K844091", "K980751", "K900204", "K172653", "K874181", "K950419", "K893488", "K973609", "K023491", "K811783", "K011442", "K812823", "K864276", "K242752", "K032789", "K910919", "K953098", "K933144", "K070125", "K813403", "K833723", "K872516", "K031185", "K844915", "K042228", "K990101", "K052221", "K865059", "K855215", "K915523", "K052217", "K944669", "K850488", "K900375", "K913056", "K082182", "K912738", "K897096", "K915499", "K861208", "K903784", "K854074", "K172831", 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