{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "122858", "product_res_number": "Z-0443-2014", "event_date_initiated": "2013-05-15", "event_date_posted": "2013-12-04", "recall_status": "Terminated", "event_date_terminated": "2014-05-13", "res_event_number": "66632", "product_code": "DWJ", "product_description": "Blanketrol III Data Export Software Version 1.10\n\nThe Blanketrol III Data Export Software is intended for use in the electronic transfer of medical device data from the Blanketrol III to a computer, without controlling or altering the function or parameters of the Blanketrol III.", "code_info": "Product/Part #86127, Catalog #USB-127, Lot #00554", "firm_fei_number": "1516825", "recalling_firm": "Cincinnati Sub-Zero Products Inc", "address_1": "12011 Mosteller Rd", "city": "Cincinnati", "state": "OH", "postal_code": "45241-1528", "additional_info_contact": "513-772-8810", "reason_for_recall": "During a customer inquiry regarding a beta version of the Bill Data Export Software, Model USB-127, it was discovered that the wrong software version was released to a customer.", "root_cause_description": "Software Manufacturing/Software Deployment", "action": "Cincinnati Sub-Zero sent a Urgent Medical Device Notification letter dated July 15, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.\n\nThey instructed their customers to to do the following:\n\n1) Upon receipt of the corrected Blanketrol III Data Export Software disc, immediately collect and destroy all previous Blanketrol III Data Export Software disc from this lot # currently in possession and replace all downloaded Blanketrol III Data Export Software with the correct version provided by CSZ.\n2) After the Blanketrol Data Export Software Version 1.00 have been destroyed and downloaded versions replaced with version 1.10, complete and return the enclosed response form as soon as possible to acknowledge receipt of this notification and to inform CSZ that you have performed and completed the requested actions. Return the form by fax to (513) 772-9119 scan and e-mail the information to BIIIExportSoftware@cszinc.com, or mail to:\nCincinnati Sub-Zero\n12011 Mosteller Road\nCincinnati, OH 45241 U.S.A.\n\nFor further questions please call 1-(800) 989-7373 or (513) 772-8810.", "product_quantity": "12 Units", "distribution_pattern": "Worldwide Distribution - US Distribution including the following states AK, CO, FL, MA, MI, and NC. and Internationally to Canada, Germany and United Kingdom.", "openfda": { "k_number": [ "K914383", "K920265", "K093244", "K001149", "K051419", "K812955", "K202197", "K903360", "K902650", "K930345", "K942599", "K232508", "K913734", "K772015", "K140635", "K051336", "K014210", "K811742", "K943276", "K881322", "K051278", "K123083", "K942790", "K001546", "K053645", "K024128", "K073712", "K171373", "K950416", "K921165", "K921920", "K180834", "K093694", "K051097", "K142702", "K920432", "K231596", "K080763", "K152266", "K040632", "K251974", "K002577", "K910327", "K100585", "K071918", "K141686", "K003349", "K232638", "K210605", "K180375", "K171149", "K210603", "K011859", "K200446", "K123946", "K102112", "K820814", "K061513", "K121720", "K252861", "K923104", "K200225", "K232502", "K022903", "K190221", "K221669", "K946196", "K033021", "K070112", "K882442", "K072513", "K021473", "K040911", "K770839", "K003368", "K231211", "K112488", "K800812", "K242964", "K132048", "K113705", "K161602", "K981093", "K140078", "K230866", "K952329", "K991684", "K854856", "K023934", "K933764", "K964377", "K101092", "K261437", "K092807", "K031728", "K873745", "K914382", "K083662", "K102856", "K181699", "K973705", "K011907", "K162562", "K882035", "K171234", "K771537", "K094056", "K232627", "K243942", "K873546", "K952864", "K940171", "K120849", "K904690", "K913016", "K101705", "K110104", "K061902", "K964673", "K162679", "K890575", "K801253", "K020604", "K101148", "K041686", "K203085", "K060865", "K260278", "K131361", "K121669", "K960167", "K132454", "K761087", "K952086", "K992386", "K071341", "K912051", "K181671", "K811743", "K914805", "K201779", "K014121", "K220941", "K900186", "K083336", "K083135", "K960511", "K902756", "K942881", "K260903", "K120081", "K062794", "K101589", "K963731", "K040440", "K232844", "K970367", "K894980", "K052392", "K010338" ], "registration_number": [ "2133810", "3014426939", "8022590", "3005997949", "3009746061", "3012421607", "3021073836", "3043226252", "3013557562", "3010380518", "3029871637", "3030597679", "2011171", "3044156918", "2029015", "3038241934", "3016844398", "2025816", "3013188547", "3005857264", "3010317211", "3004491421", "3010168054", "9611590", "9617473", "1516825", "3041276890", "3035108304", "3008879776", "1055823", "3012689738", "3003857828", "1219702", "1066427", "1725056", "3005941719", "3005238200", "3012494290", "3004362278", "3031841433", "1043572", "3018094310", "3036108847", "3012972101", "9616096", "9680284", "9614306", "3010476117", "3013319212", "9616567", "1722070", "1000122786", "3042272797", "1043214", "3013410562", "3014421917", "3009093866", "3003542872", "3008352384", "3009609358", "1018233", "1060680", "1417592", "3011059079", "3010617000", "1055236", "3012315097", "1836518", "3007309299", "3006240053", "2936999", "2530138", "3008727520", "1220351", "3014263632", "2432320", "3032911850", "1000484830", "2183744", "1054241", "1043644", "2320762", "2133641", "9617604", "2032112", "3016507522", "3034393266", "3013041594", "3007616088", "9610849", "2183613" ], "fei_number": [ "1000208624", "3014426939", "3005997949", "3009746061", "3012421607", "3021073836", "3043226252", "3003793491", "3013557562", "3010380518", "3029871637", "1000221205", "3002807111", "1000111140", "1000160458", "1000117260", "3030597679", "2011171", "3044156918", "3038241934", "3016844398", "2025816", "3000203466", "3003807323", "3013188547", "3005857264", "3010317211", "3004491421", "3010168054", "3001733054", "1516825", "3041276890", "3035108304", "3003076831", "3007513035", "3008879776", "1000237915", "3002558692", "1000112877", "3012689738", "3003857828", "1219702", "3003040625", "3005238200", "3012494290", "3004362278", "3002809016", "3003261020", "3031841433", "1043572", "3018094310", "3036108847", "3012972101", "3010476117", "3013319212", "1000122786", "3042272797", "1000112968", "1043214", "3002807391", "3013410562", "3495", "3014421917", "3009093866", "3003542872", "3008352384", "3009609358", "1018233", "3003329224", "1417592", "3011059079", "3003753496", "3012315097", "3007309299", "3006240053", "1000521377", "2936999", "3008727520", "1220351", "3014263632", "3032911850", "1000484830", "2183744", "1043644", "3016507522", "3034393266", "3000203066", "3002963732", "3013041594", "3007616088", "2183613" ], "device_name": "System, Thermal Regulating", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5900", "device_class": "2" } } ] }