{ "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": "88575", "product_res_number": "Z-0895-2010", "event_date_initiated": "2009-12-17", "event_date_posted": "2010-03-01", "recall_status": "Terminated", "event_date_terminated": "2012-04-19", "res_event_number": "54487", "product_code": "DWJ", "k_numbers": [ "K053645", "K060865" ], "product_description": "Electri-Cord Manufacturing Corporation (312 E. Main St., Westfield, PA 16950) AC power cords used with either Bair Paws Temperature Management Units: Models 850 and 875\nBair Hugger Temperature Management Units: Models 500/OR, 505, 750 and 775\n\nIndicated for hyper- or hypothermic patients or normothermic patients, for whom induced hyper- hypothermia or localized temperature therapy is clinically indicated. In addition, the temperature management systems can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients.", "code_info": "Part number 502221 Model 90024", "firm_fei_number": "2183725", "recalling_firm": "Arizant Inc", "address_1": "10393 W 70th St", "city": "Eden Prairie", "state": "MN", "postal_code": "55344", "additional_info_contact": "952-941-8866", "reason_for_recall": "Arizant Healthcare Inc. is initiating a nationwide voluntary recall of 100/110-volt power cords (Arizant part number 502221 Model 90024) attached to its temperature management units and pressure infusion power pack (Bair Paws Temperature Management Units: Models 850 and 875\nBair Hugger Temperature Management Units: Models 500/OR, 505 (Human & Vet.), 750 (Human & Vet) and 775\nRanger Blood/Flui", "root_cause_description": "Nonconforming Material/Component", "action": "An \"Urgent Medical Device Power Cord Recall\" letter dated December 17, 2009 was sent to customers. The letter was addressed to Recall Coordinator/Biomed Dept. The letter described the affected product, problem, hazard involved, and action to be taken by customer. \n\nThe customers are being ask to inspect their temperature management units (as described in FDA's recommendation dated October 19, 2009) and contact the firm with the results of their inspection and provide a contact name via website www.arizant.com/powercords or phone (877) 947-1487. Replacement cords and instructions will be provided to customers based on priority listed in the letter and availability of replacement cords. If the customer does not have the means to make the changes, alternate means will be taken (i.e., an Arizant employee or outside service organizations may be brought in to do the replacements).\n\nIf you have any questions, please contact the Aziant at (877) 47-1487.", "product_quantity": "Total distributed for all devices: 84,537 US, 7,380 OUS.", "distribution_pattern": "Worldwide Distribution: USA and ARGENTINA, THE BAHAMAS, CANADA, COLOMBIA, COSTA RICA, CUBA, DOMINICAN REPUBLIC, ECUADOR, GERMANY, GUAM, JAPAN, LEBANON, MEXICO, NICARAGUA, PANAMA, PUERTO RICO, QATAR, SAUDI ARABIA, SOUTH KOREA, SURINAME , TAIWAN, TRINIDAD AND TOBAGO, QATAR.", "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", 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"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", 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"regulation_number": "870.5900", "device_class": "2" } } ] }