{ "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": "211102", "product_res_number": "Z-0701-2025", "event_date_initiated": "2024-12-04", "event_date_posted": "2024-12-18", "recall_status": "Open, Classified", "res_event_number": "95703", "product_code": "DWJ", "k_numbers": [ "K201779", "K220941" ], "product_description": "Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: \n1) Model # WC77, \n2) Model # WC77D (Demo), \n3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.", "code_info": "1) UDI-DI 00850011479025, Serial Numbers: 20080060-24060065; \n2) UDI/DI 00850011479292, Serial Numbers: 20080060-24060065; \n3) UDI-DI 00850011479308, Serial Numbers: 20080060-24060065", "firm_fei_number": "3005857264", "recalling_firm": "Augustine Temperature Management, LLC", "address_1": "15305 Minnetonka Blvd", "city": "Minnetonka", "state": "MN", "postal_code": "55345-1512", "additional_info_contact": "Nic Raph\n952-465-3500", "reason_for_recall": "Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code \"EA POST\".", "root_cause_description": "Device Design", "action": "Augustine Temperature Management issued a Field Notification to its consignees on 12/04/2024 via email. The notice explained the issue, potential risk, and advised that there is an update to the User and Technical Manual to further clarify existing instructions for the device. \nIf the device was further distributed, those distributing the device were directed to notify those to whom the device was distributed. Consignees are expected to respond via email. \nAn optional power board update is available. \nFor questions or concerns, contact: customercare@augsurg.com or by telephone, 952-465-3500, fax, 952-465-3501, 8AM - 5PM Central time.", "product_quantity": "1776 units", "distribution_pattern": "US and Canada", "openfda": { "k_number": [ "K912051", "K873745", "K942881", "K041686", "K946196", "K910327", "K251974", "K923104", "K180834", "K940171", "K921165", "K991684", "K970367", "K252861", "K022903", "K964377", "K220941", "K881322", "K210605", "K112488", "K132454", "K102112", "K992386", "K181699", "K040911", "K811743", "K071918", "K020604", "K121669", "K101589", "K120849", "K232502", "K083135", "K232638", "K800812", "K232627", "K914382", "K051097", "K002577", "K882442", "K950416", "K093694", "K060865", "K801253", "K771537", "K920265", "K051336", "K952864", "K014210", "K854856", "K080763", "K201779", "K210603", "K921920", "K132048", "K031728", "K001149", "K903360", "K920432", "K261437", "K040440", "K202197", "K242964", "K101705", "K772015", "K113705", "K181671", "K011859", "K083662", "K180375", "K014121", "K960511", "K141686", "K070112", "K820814", "K770839", "K110104", "K123083", "K131361", "K203085", "K914383", "K083336", "K890575", "K062794", "K061513", "K943276", "K101148", "K811742", "K882035", "K021473", "K902650", "K952086", "K930345", "K024128", "K003368", "K162679", "K981093", "K963731", "K960167", "K120081", "K071341", "K230866", "K162562", "K190221", "K171149", "K952329", "K894980", "K913016", "K221669", "K140635", "K121720", "K231596", "K001546", "K094056", "K051278", "K011907", "K973705", "K142702", "K072513", "K913734", "K942790", "K093244", "K061902", "K900186", "K140078", "K053645", "K003349", "K101092", "K873546", "K100585", "K033021", "K964673", "K260903", "K051419", "K904690", "K232844", "K023934", "K052392", "K914805", "K102856", "K232508", "K200446", "K010338", "K942599", "K152266", "K231211", "K092807", "K933764", "K161602", "K243942", "K171234", "K200225", "K073712", "K123946", "K260278", "K761087", "K171373", "K040632", "K812955", "K902756" ], "registration_number": [ "3042272797", "2029015", "3030597679", "1060680", "3010617000", "3004491421", "3009093866", "3008352384", "3007309299", "3011059079", "1417592", "3021073836", "2025816", "3008727520", "1219702", "9610849", "9617604", "3014421917", "3035108304", "3041276890", "3012972101", "9616096", "1055823", "2011171", "3009746061", "3018094310", "3008879776", "2032112", "3043226252", "2936999", "3010168054", "3006240053", "1043572", "3010476117", "2432320", "3007616088", "3009609358", "1725056", "3013319212", "9680284", "1220351", "3031841433", "3013410562", "3005941719", "3012494290", "1000484830", "3012421607", "1000122786", "3012315097", "3010380518", "1043214", "3005857264", "3013041594", "1722070", "3012689738", "1066427", "3014426939", "1043644", "3029871637", "2133810", "3010317211", "2133641", "9614306", "9611590", "3013557562", "3016844398", "3044156918", "3034393266", "8022590", "2183613", "3013188547", "1018233", "1055236", "3003857828", "3038241934", "3005997949", "9616567", "3003542872", "1516825", "2183744", "3004362278", "1836518", "3016507522", "2530138", "9617473", "1054241", "3032911850", "3036108847", "2320762", "3014263632", "3005238200" ], "fei_number": [ "3042272797", "3007513035", "3030597679", "3004491421", "3009093866", "3008352384", "3007309299", "1000208624", "3011059079", "1417592", "3003040625", "3021073836", "2025816", "3008727520", "3002807391", "3001733054", "1219702", "3014421917", "3035108304", "3041276890", "3012972101", "3002807111", "2011171", "3003076831", "3009746061", "3018094310", "3008879776", "3003807323", "3043226252", "2936999", "3010168054", "3006240053", "3000203466", "1043572", "3010476117", "3003261020", "3007616088", "3009609358", "3013319212", "1220351", "3031841433", "3013410562", "1000160458", "3495", "3012494290", "1000484830", "3012421607", "1000521377", "1000122786", "1000117260", "3012315097", "3010380518", "1043214", "3005857264", "3013041594", "1000112968", "3002963732", "3012689738", "3014426939", "1043644", "3029871637", "1000111140", "3010317211", "3003753496", "3003793491", "3013557562", "3016844398", "1000237915", "3044156918", "3034393266", "1000221205", "2183613", "3013188547", "3000203066", "1018233", "1000112877", "3003857828", "3002558692", "3038241934", "3005997949", "3003329224", "3003542872", "1516825", "2183744", "3004362278", "3016507522", "3032911850", "3036108847", "3002809016", "3014263632", "3005238200" ], "device_name": "System, Thermal Regulating", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5900", "device_class": "2" } } ] }