{ "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": "2026-09-03", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "221197", "product_res_number": "Z-2759-2026", "event_date_initiated": "2026-06-24", "event_date_posted": "2026-07-17", "recall_status": "Open, Classified", "res_event_number": "99289", "product_code": "LGZ", "k_numbers": [ "K911383" ], "product_description": "Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions, List Number L-70", "code_info": "UDI-DI: 30695085407007;\nLot Numbers: 4293568, 4293569, 4297510, 4297509, 4326087, 4337724, 4337725, 4346349", "firm_fei_number": "3012307300", "recalling_firm": "ICU Medical Inc.", "address_1": "6000 Nathan Ln N", "city": "Minneapolis", "state": "MN", "postal_code": "55442-1690", "reason_for_recall": "ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond.", "root_cause_description": "Process control", "action": "An URGENT: MEDICAL DEVICE CORRECTION notification letter dated 6/24/26 was sent to customers.\n\nActions for Users:\nWhen using the device, all instructions, including warnings and cautions contained in the Instructions for Use must be followed with heightened awareness. Please complete the following actions below.\n1. Locate potentially affected devices from the Lots listed in Table 1 above.\n2. Destroy all affected products following your institution s process for destruction. If destroying is not immediately possible at your facility, then the product should be quarantined until disposal.\n3. Share this notification with all potential users of the device to ensure they are aware of this notification. If the devices are used at another location, please ensure that this communication is delivered there.\n4. Complete and return the attached Customer Response Form to MarketAction@mailac.custhelp.com within 10 days of receipt to acknowledge your understanding of this notification.\n\nRequired Actions for Distributors:\nWhen using the device, all instructions, including warnings and cautions contained in the Instructions for Use must be followed with heightened awareness. Please complete the following actions below.\n1. Locate potentially affected devices from the Lots listed in Table 1 above.\n2. Destroy all affected products following your institution s process for destruction. If destroying is not immediately possible at your facility, then the product should be quarantined until disposal.\n3. Share this notification with all potential users of the device to ensure they are aware of this notification. If the devices are used at another location, please ensure that this communication is delivered there.\n4. Complete and return the attached Customer Response Form to MarketAction@mailac.custhelp.com within 10 days of receipt to acknowledge your understanding of this notification.\n5. DISTRIBUTORS: Immediately forward this notice to all users to whom you distributed these products. IC", "product_quantity": "39,750 units", "distribution_pattern": "Worldwide - US Nationwide distribution.", "openfda": { "k_number": [ "K091336", "K803249", "K180154", "K092823", "K131519", "K911383", "K111870", "K260988", "K060537", "K251733", "K955659", "K103801", "K001764", "K110769", "K112902", "K024373", "K132202", "K070654", "K012832", "K973748", "K023653", "K211800", "K213191", "K002409", "K072080", "K202461", "K041839", "K152208", "K822098", "K180842", "K120026", "K150404", "K121775", "K121198", "K813161", "K980086", "K052055", "K082765", "K914364", "K012906", "K112702", "K192325", "K102900", "K132110", "K171215", "K062644", "K031390", "K073363", "K082217", "K060851", "K882361", "K922786", "K981509", "K896018", "K954769", "K921395", "K012276", "K130867", "K092366", "K120860", "K060939", "K122449", "K904252", "K252636", "K032778", "K883873", "K914867", "K090089", "K161613", "K211618", "K232107", "K150484", "K181775", "K163708", "K032674" ], "registration_number": [ "1643817", "3007127244", "2032112", "3009988302", "3003793891", "3010317211", "3003144120", "2936485", "3030125051", "3008959444", "3021073836", "3007495879", "3032580628", "3013557562", "3005730406", "3004167615", "3010432890", "3009746061", "3005382983", "2031963", "2183744", "3031841433", "3003464075", "2427500", "1000312731", "3006946102", "2246552", "1825014", "1220477", "9617473", "9681599", "3010876604", "3036108847", "9617604", "3006715577", "1043572", "3013319212", "2024242", "3005813632", "3008258694", "3042272797", "3003018722", "1054811", "3006158088", "3008388260", "3003018304", "2032098", "1649518", "9614609", "2528981", "3003771969", "3012494290", "3038241934", "3004491421", "1314417", "3006405073", "9616074", "3020978007", "1125615", "3012302888", "1419937", "3013429468", "1219702", "1650754", "3006342679", "3005941719", "3010663836", "9616567", "3008773490", "2244478", "1033902", "1058584" ], "fei_number": [ "1643817", "3007127244", "3009988302", "3003793891", "3002963732", "1000136269", "3003076831", "3010317211", "2936485", "3030125051", "3008959444", "3021073836", "3007495879", "3032580628", "3013557562", "3002558692", "3005730406", "3004167615", "3010432890", "3009746061", "3005382983", "3004099094", "2183744", "3031841433", "3003464075", "3001733054", "1000312731", "2427500", "3006946102", "2246552", "1825014", "3002732397", "1220477", "3002587972", "3010876604", "3036108847", "3006715577", "1000219637", "1043572", "3002807111", "3013319212", "2024242", "1000114185", "3008258694", "3005813632", "3001236277", "3042272797", "3003018722", "3006158088", "3008388260", "3003018304", "3002654698", "2528981", "3002930098", "1000484507", "3003771969", "3012494290", "3038241934", "3004491421", "1314417", "3006405073", "3020978007", "3003058448", "3012302888", "1419937", "3013429468", "1219702", "3006342679", "3010663836", "3008773490", "3002975342", "1033902" ], "device_name": "Warmer, Thermal, Infusion Fluid", "medical_specialty_description": "General Hospital", "regulation_number": "880.5725", "device_class": "2" } } ] }