{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "105687", "product_res_number": "Z-0428-2012", "event_date_initiated": "2011-11-21", "event_date_posted": "2012-01-11", "recall_status": "Terminated", "event_date_terminated": "2014-08-07", "res_event_number": "60516", "product_code": "LGZ", "k_numbers": [ "K911383" ], "product_description": "Level 1 Normothermic I.V. Fluid Administration Sets,\nProduct Code DI-60HL ,\n\nProduct Usage: Single patient use sets designed for use by trained medical professionals, in conjunction with Level 1 Fast Flow Fluid Warmers (H1000, H-1025, H-1028, and H-1200), for the warming and delivery of blood and I.V. solutions, at flow rates of 75ml/min - 530 ml/min.", "code_info": "Lot Numbers: 2033447 2039136 2046398 2046400 2047961 2047963 2064528 2064529 2064530 2077404 2077405 2077406 2077407 2087667 2099050 2099766 2102361", "firm_fei_number": "1221261", "recalling_firm": "Smiths Medical ASD, Inc.", "address_1": "160 Weymouth St", "city": "Rockland", "state": "MA", "postal_code": "02370-1136", "additional_info_contact": "SA ME\n781-878-8011", "reason_for_recall": "Disconnected/ loose Luer connectors at the patient end of the triple lumen tubing of the HOTLlNE Disposable Administration Sets and Level 1 D/DI-60HL Normothermic IV Administration Sets", "root_cause_description": "Device Design", "action": "Smiths Medical notified consignees by letter dated November 28, 2011 titled: Urgent Field Safety Notice. The letter identified the affected product, the problem, and the actions to be taken. Customers were instructed to inspect inventory and segregate unused affected product. Distributors were instructed to immediately stop distributing and quarantine all inventory. The letters included a Confirmation Form to be complete and return, by fax to 781-610-9859 or by email to hotlineconnectorrecall@smiths-medical.com. \nFor questions consignees were instructed to contact Smiths Medical at 1781-763-9330.", "product_quantity": "7631 units", "distribution_pattern": "Worldwide Distribution (USA) (nationwide) - Argentina, Austria, Australia, Belgium, Bahrain, Bermuda, Canada, Chile, China, Columbia, Czech Republic, Germany, Denmark, Estonia, Egypt, Finland, France, Great Britain, Guernsey, Greece, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Israel \nIndia, Iceland, Italy, Japan, South Korea, Kazakhstan, Lebanon, Luxembourg, Mexico, Malaysia, New Caledonia, Netherlands, Norway, New Zealand, Panama, Poland, Portugal, Qatar, Singapore, Sweden, Slovak Republic, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, and Vatican City State.", "openfda": { "k_number": [ "K092366", "K103801", "K073363", "K904252", "K914867", "K060851", "K152208", "K062644", "K150404", "K082217", "K202461", "K914364", "K122449", "K130867", "K161613", "K896018", "K024373", "K120860", "K150484", "K091336", "K213191", "K180842", "K012276", "K163708", "K955659", "K813161", "K911383", "K112902", "K032674", "K883873", "K181775", "K111870", "K171215", "K232107", "K954769", "K102900", "K260988", "K882361", "K112702", "K922786", "K072080", "K121775", "K131519", "K121198", "K252636", "K032778", "K031390", "K052055", "K012906", "K211800", "K092823", "K981509", "K001764", "K110769", "K002409", "K822098", "K041839", "K090089", "K012832", "K973748", "K023653", "K803249", "K251733", "K082765", "K132110", "K060939", "K180154", "K060537", "K120026", "K980086", "K070654", "K921395", "K211618", "K132202", "K192325" ], "registration_number": [ "1419937", "1825014", "3020978007", "2032098", "3032580628", "1000312731", "1054811", "1125615", "3012494290", "1220477", "3030125051", "9681599", "3010663836", "3005382983", "2024242", "2244478", "3003144120", "9614609", "3010876604", "3010432890", "3008773490", "3036108847", "1649518", "3005813632", "9616567", "1314417", "3003771969", "1043572", "9616074", "9617473", "2031963", "1643817", "3008959444", "9617604", "3005941719", "3004491421", "1033902", "2032112", "3006946102", "3006342679", "3004167615", "3010317211", "3007127244", "3008388260", "3013429468", "3007495879", "2936485", "2183744", "2528981", "1650754", "3012302888", "3003018722", "3013557562", "2246552", "3042272797", "3003793891", "3006158088", "3006715577", "3009746061", "1219702", "3009988302", "3005730406", "3031841433", "3038241934", "3008258694", "3013319212", "3003018304", "3006405073", "2427500", "1058584", "3003464075", "3021073836" ], "fei_number": [ "1419937", "1000219637", "1825014", "3001236277", "3020978007", "3004099094", "3032580628", "1000312731", "3002587972", "3012494290", "3003076831", "1220477", "3030125051", "3010663836", "3005382983", "2024242", "3001733054", "3010876604", "3010432890", "3008773490", "3036108847", "3005813632", "3002732397", "1314417", "3003771969", "1043572", "1643817", "3008959444", "3004491421", "1033902", "3006946102", "3006342679", "3004167615", "3010317211", "3007127244", "3008388260", "3002807111", "3013429468", "3007495879", "2936485", "1000484507", "3002975342", "2183744", "2528981", "3006158088", "3012302888", "3003018722", "3013557562", "2246552", "3042272797", "3003793891", "1000114185", "3002930098", "3006715577", "3009746061", "1000136269", "3009988302", "3002963732", "3005730406", "3031841433", "3038241934", "3008258694", "3002654698", "3013319212", "3003018304", "3002558692", "3006405073", "2427500", "1219702", "3003464075", "3021073836", "3003058448" ], "device_name": "Warmer, Thermal, Infusion Fluid", "medical_specialty_description": "General Hospital", "regulation_number": "880.5725", "device_class": "2" } } ] }