{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "222072", "product_res_number": "Z-3212-2026", "event_date_initiated": "2026-08-20", "event_date_posted": "2026-09-17", "recall_status": "Open, Classified", "res_event_number": "99648", "product_code": "LHI", "k_numbers": [ "K162219" ], "product_description": "CADD Yellow Medication Cassette Reservoir with NRFit connector\n\nUS Product Codes: 21-7600-24, 21-7609-24\n\nOUS Product Codes:\n21-7609-24\n21-7600-24\n21-7600-24\n21-7600-24\n21-7609-24\n21-7609-24\n21-7600-24\n21-7600-24\n21-7609-24\n21-7609-24\n21-7600-24\n21-7600-24\n21-7609-24\n21-7600-24\n21-7600-24\n21-7609-24\n21-7609-24JP\n21-7600-24JP\n21-7609-24\n21-7609-24\n21-7600-24\n21-7600-24\n21-7609-24\n21-7600-24\n21-7600-24\n21-7600-24\n21-7609-24", "code_info": "21-7600-24\nUDI-DI 30610586044001\nLots 6026878\n6037784\n6054015\n6062724\n6070616\n6082332\n6092886\n6101906\n6108556\n6126029\n6140893\n6143454\n6147696\n6147697\n6162769\n6155095\n6166032\n6171587\n6171586\n\n\n21-7609-24\nUDI-DI 30610586044018\nLot 6022079\n6037697\n6037698\n6053978\n6061525\n6072970\n6072964\n6070575\n6077773\n6092846\n6101798\n6108514\n6108515\n6108516\n6140862\n6140861\n6140865\n6155132", "firm_fei_number": "3013319212", "recalling_firm": "ICU Medical, Inc.", "address_1": "600 N Field Dr", "city": "Lake Forest", "state": "IL", "postal_code": "60045-4835", "additional_info_contact": "Customer Service\n800-258-5361", "reason_for_recall": "Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, exposure to infectious or toxic agents, or air embolus.", "root_cause_description": "Process control", "action": "On August 20, 2026, the firm began notifying affected customers via Urgent Medical Device Correction letters. Customers were informed that certain reservoirs may exhibit fluid leakage at the joint between the connector and the tubing.\n\nCustomers were instructed to check all inventory locations for affected product and discontinue use. All affected products should be destroyed following their institution's destruction process. If destruction is not immediately possible at your facility, quarantine the products until disposal.\n\nCustomers should share the notification with all potential users of the reservoirs, and notify any accounts to whom the affected products have been further distributed.\n\nThe firm will provide replacement products to affected customers upon receipt of a completed Customer Response Form to certify product destruction.", "product_quantity": "185,688 units", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of AR, CA, FL, IL, IN, LA, MI, MO, MS, \nTN, TX, VA, WI and the countries of Austria, Australia, Belgium, Costa Rica, Germany, Estonia, Spain, Finland, France, Great Britain, Ireland, Italy, Japan, Kuwait, Netherlands, Norway, and Sweden.", "openfda": { "k_number": [ "K925401", "K241976", "K834500", "K083851", "K212445", "K022523", "K860434", "K832312", "K233284", "K080174", "K100640", "K140442", "K172884", "K243404", "K961008", "K901063", "K010703", 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"3009265194", "3017636737", "3002807038", "3001237677", "3006979803", "1000632857", "3002807880", "2245590", "2648209", "3003674698", "3030626857", "3003094851", "3010329663", "3008717264", "3011554160", "1314417", "3003152976", "3002807257", "3002806469", "3000215205", "3000147578", "3000215273", "1417592", "3015972753", "3002907620", "2520313", "1037885", "3006571738", "3002710954", "1416980", "3009340644", "3002807139", "3013319212", "3007221462", "3002963732", "1000518731", "3030201489", "3013188547", "1217831", "3045751639", "3023851856", "1047843", "3002807555", "1000120555", "2521402", "3003704957", "3003965134", "3010659131", "3000327333", "3018125942", "3030447506", "1000136269", "3017406698", "3010432890", "1000115518" ], "device_name": "Set, I.V. Fluid Transfer", "medical_specialty_description": "General Hospital", "regulation_number": "880.5440", "device_class": "2" } } ] }