{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "105683", "product_res_number": "Z-0424-2012", "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": "HOTLlNE Disposable Administration Sets,\nProduct Code L-270\n\nProduct Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE Routine Flow Blood and Fluid Warmers (HL-90 and HL-290), for the warming and delivery of blood and I.V. solutions, at normothermic flow rates of 50 - 5,000 ml/hr.", "code_info": "Lot Numbers: 1947531 1952652 1957058 1957059 1967245 1967246 1979007 1995553 1995693 1998983 1998984 2019637 2019638 2019639 2025120 2025121 2038143 2038144 2038146 2038147 2049439 2059469 2059470 2064010 2068137 2077198 2077199 2077200 2090779", "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": "60,084 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": [ "K211618", "K163708", "K803249", "K252636", "K955659", "K120026", "K091336", "K904252", "K024373", "K150404", "K032778", "K023653", "K132202", "K211800", "K012906", "K980086", "K012832", "K110769", "K914867", "K121775", "K181775", "K060851", "K082765", "K973748", "K130867", "K060939", "K070654", "K082217", "K062644", "K120860", "K012276", "K032674", "K954769", "K152208", "K112702", "K981509", "K002409", "K072080", "K202461", "K060537", "K132110", "K813161", "K121198", "K911383", "K260988", "K882361", "K171215", "K180842", "K103801", "K073363", "K001764", "K213191", "K131519", "K180154", "K896018", "K031390", "K921395", "K112902", "K922786", "K150484", "K914364", "K192325", "K052055", "K111870", "K161613", "K041839", "K092823", "K251733", "K883873", "K232107", "K092366", "K122449", "K822098", "K102900", "K090089" ], "registration_number": [ "3010432890", "3042272797", "3005382983", "2936485", "3003464075", "3006946102", "2024242", "1054811", "3009746061", "3010663836", "2031963", "3012494290", "3006158088", "3004491421", "1058584", "1033902", "1419937", "2032098", "3009988302", "3038241934", "3005813632", "3008258694", "2032112", "3032580628", "3008388260", "1643817", "2427500", "3006342679", "3005730406", "9614609", "3008959444", "3003144120", "9681599", "1125615", "3006405073", "3006715577", "2246552", "3030125051", "3021073836", "9616567", "3007495879", "3010876604", "3003771969", "1650754", "3003793891", "2244478", "3003018722", "1043572", "2183744", "1649518", "3008773490", "3007127244", "3010317211", "1219702", "9617604", "9616074", "9617473", "1314417", "1220477", "3004167615", "3020978007", "3036108847", "3003018304", "3013319212", "3013429468", "1000312731", "3013557562", "2528981", "3012302888", "3031841433", "1825014", "3005941719" ], "fei_number": [ "3010432890", "3042272797", "3005382983", "2936485", "3003464075", "3006946102", "2024242", "1000219637", "3004099094", "3009746061", "3010663836", "3003076831", "3001236277", "3012494290", "3006158088", "3004491421", "3002558692", "1033902", "1419937", "3005813632", "3009988302", "3038241934", "3006342679", "3008258694", "3002654698", "3032580628", "1643817", "1000114185", "2427500", "1000484507", "3005730406", "3002732397", "3008959444", "1000136269", "3006405073", "3006715577", "2246552", "3030125051", "3021073836", "3007495879", "3010876604", "3002963732", "3003771969", "3002975342", "3003793891", "3003018722", "1043572", "2183744", "3008773490", "3007127244", "3010317211", "3001733054", "1219702", "3002930098", "1314417", "1220477", "3004167615", "3002587972", "3020978007", "3003058448", "3036108847", "3003018304", "3013319212", "3013429468", "1000312731", "3013557562", "2528981", "3012302888", "3002807111", "3031841433", "1825014", "3008388260" ], "device_name": "Warmer, Thermal, Infusion Fluid", "medical_specialty_description": "General Hospital", "regulation_number": "880.5725", "device_class": "2" } } ] }