{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "188709", "product_res_number": "Z-2376-2021", "event_date_initiated": "2021-08-06", "event_date_created": "2021-09-03", "recall_status": "Open, Classified", "res_event_number": "88455", "product_code": "LGZ", "k_numbers": [ "K072080" ], "product_description": "NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129", "code_info": "Model H-1100: Product Codes CON-H1100, H-1100, H-1100-ES-115V, H-1100-ES-230V, H-1100-FR-230V, H-1100-INT-230, H-1100-IT-230V, H-1100-NL-230V H-1100-SV-230V, H-1100-UK-230  Model H-1129: Product Code H-1129", "firm_fei_number": "3012307300", "recalling_firm": "Smiths Medical ASD Inc.", "address_1": "6000 Nathan Ln N", "city": "Minneapolis", "state": "MN", "postal_code": "55442-1690", "additional_info_contact": "Dave Halverson\n763-383-3072", "reason_for_recall": "There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use.", "root_cause_description": "Device Design", "action": "Smiths Medical sent an Urgent Medical Device Recall Notice and attachments dated August 13, 2021 to all affected customers. The letter instructed all customers who purchased affected devices listed in the table on page 1 of the Urgent Medical Device Recall Notice must identify any of the affected products within their possession and refer to the detailed instructions on pages 2 and 3 of the notice.\n\nDistributors will be instructed to immediately forward a copy of the Urgent Medical Device Recall Notice and attachments to any customers to whom they have distributed affected product. Distributors will also be instructed to request that customers to who they have distributed affected product complete the Response Form and return it to the distributor. Distributors will indicate their identity as the distributor and document the consignees name and address.\n\nQuestions regarding this recall notification may be forwarded to fieldactions@smiths-medical.com.", "product_quantity": "913", "distribution_pattern": "US Nationwide Distribution and PR\n\nOUS distribution in - Austria, Australia, Belgium, Switzerland, Canada, Germany, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Hungary, Ireland, Italy, Kuwait, Luxembourg, Netherlands, New Zealand, Panama, Poland, Portugal, Sweden, Turkey, Venezuela, South Africa", "openfda": { "k_number": [ "K060851", "K110769", "K192325", "K150404", "K120860", "K092823", "K260988", "K803249", "K062644", "K981509", "K132110", "K904252", "K180842", "K180154", "K041839", "K092366", "K922786", "K012832", "K023653", "K883873", "K921395", "K002409", "K052055", "K103801", "K070654", "K111870", "K082217", "K082765", "K202461", "K132202", "K031390", "K120026", "K161613", "K060939", "K914867", "K251733", "K232107", "K012906", "K954769", "K024373", "K060537", "K091336", "K122449", "K211618", "K252636", "K211800", "K181775", "K131519", "K102900", "K012276", "K171215", "K896018", "K001764", "K152208", "K955659", "K072080", "K130867", "K150484", "K032674", "K073363", "K822098", "K914364", "K112702", "K213191", "K973748", "K813161", "K121198", "K163708", "K032778", "K112902", "K980086", "K090089", "K911383", "K121775", "K882361" ], "device_name": "Warmer, Thermal, Infusion Fluid", "medical_specialty_description": "General Hospital", "regulation_number": "880.5725", "device_class": "2", "registration_number": [ "3009746061", "3010663836", "1825014", "3003144120", "3006715577", "3004167615", "3042272797", "9681599", "1125615", "3010317211", "3009988302", "9616074", "2024242", "3007495879", "3005813632", "1314417", "1650754", "3005730406", "3008388260", "9614609", "2246552", "3031841433", "3006158088", "3010432890", "1054811", "3013429468", "3006405073", "2427500", "3030125051", "2936485", "2031963", "3008258694", "9617473", "3010876604", "2032098", "3008773490", "1033902", "3003771969", "1220477", "1000312731", "3020978007", "3005382983", "3007127244", "3005941719", "3013319212", "3003018304", "3021073836", "1649518", "3004491421", "3012494290", "3012302888", "2032112", "3032580628", "3038241934", "2244478", "2528981", "1643817", "9617604", "3036108847", "3008959444", "3003793891", "3006946102", "3003018722", "3013557562", "3003464075", "1043572", "3006342679", "1058584", "1219702", "2183744", "1419937", "9616567" ], "fei_number": [ "3002654698", "3002558692", "1000114185", "3009746061", "3010663836", "1825014", "3002930098", "3006715577", "3004167615", "3002732397", "3042272797", "1000136269", "3010317211", "3009988302", "2024242", "3007495879", "3005813632", "1314417", "3004099094", "3005730406", "3008388260", "2246552", "3031841433", "3006158088", "3010432890", "3003058448", "3013429468", "3006405073", "3002807111", "3002975342", "2427500", "3030125051", "2936485", "3008258694", "3010876604", "3003076831", "3008773490", "1033902", "1000219637", "3003771969", "1220477", "2183744", "1000312731", "3020978007", "3002963732", "3005382983", "3007127244", "3013319212", "3003018304", "1000484507", "3021073836", "3004491421", "3012494290", "3012302888", "3032580628", "3038241934", "2528981", "1643817", "3036108847", "3008959444", "3003793891", "3002587972", "3003018722", "3006946102", "3013557562", "3003464075", "1043572", "3006342679", "3001733054", "1219702", "3001236277", "1419937" ] } } ] }