{ "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": "105684", "product_res_number": "Z-0425-2012", "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-370\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: 1995695 1995696 2038150 2038151 2038152 2047423 2061923 2061924 2061929 2061930 2061931 2061932 2061933 2077201 2077202 2090780 2090781 2095295 2095302 2095306", "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": "36,421 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" } } ] }