{ "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": "176415", "product_res_number": "Z-0247-2020", "event_date_initiated": "2019-09-19", "event_date_posted": "2019-10-30", "recall_status": "Terminated", "event_date_terminated": "2020-12-11", "res_event_number": "83816", "product_code": "KDI", "k_numbers": [ "K190910" ], "product_description": "TherMax Blood Warmer Unit", "code_info": "Product Code: 955630, UDI: 00085412639505, Serial Numbers: 101332, 101335, 101358, 101369, 101402, 101403, 101404, 101406, 101415, 101416, 101429, 101430, 101437, 101439, 101440, 101441, 101443.   Product Code: 955515, Serial Numbers 100261, 100263, 100280, 100281, 100282, 100283, 100284, 100285, 100286, 100287, 100288, 100289, 100290, 100291, 100292, 100294, 100296, 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101251, 101252, 101253, 101254, 101255, 101256, 101257, 101258, 101259, 101271, 101272, 101273, 101274, 101276, 101277, 101278, 101458, 101460, 101469, 101470, 101471, 101472, 101473, 101474, 101475, 101476, 101477, 101478, 101479, 101480, 101481, 101482, 101483, 101484, 101485, 101486, 101487, 101488, 101489, 101490, 101491, 101492, 101508, 101509, 101510, 101511, 101512, 101513, 101514, 101515, 101516, 101517, 101519, 101520, 101521, 101522, 101538, 101539, 101540, 101541, 101542, 101543, 101544, 101545, 101546, 101547, 101548, 101549, 101550, 101551, 101552, 101553, 101554, 101555, 101556, 101557, 101558, 101559, 101560, 101561, 101562, 101593, 101594, 101595, 101596, 101597, 101598, 101599, 101600, 101601, 101602, 101603, 101604, 101605, 101607.", "firm_fei_number": "1417572", "recalling_firm": "Baxter Healthcare Corporation", "address_1": "1 Baxter Pkwy", "city": "Deerfield", "state": "IL", "postal_code": "60015-4625", "reason_for_recall": "TherMax Blood Warmers may not be in compliance with an electrical safety standard, which requires a protective earth\nconnection that can sustain a current of 25 amps for 10 seconds.", "root_cause_description": "Device Design", "action": "Baxter Healthcare notified customers on about 09/19/2019, via \"URGENT MEDICAL DEVICE CORRECTION\" letter. Customers were informed that specific TherMax Blood Warmers listed below may not be in compliance with an electrical safety standard, which requires a protective earth connection that can sustain a current of 25 amps for 10 seconds. The affected units may not have an adequate ground path, which could cause the units to become damaged if used with improperly grounded outlets. The damage could cause the TherMax Blood Warmer units to be nonfunctional during clinical use. \n\nInstructions included that customers could continue to safely use affected devices with a properly grounded outlet, that a local Baxter representative will contact each facility to arrange for the correction of affected devices, to complete and return the Baxter Customer Reply Form via fax to 224-270-5457 or scanning and e-mailing it to fca@baxter.com, and to notify customers if the product was further distributed. \n\nFor general questions regarding this communication, contact Baxter Corporate Product Surveillance at 800-437-5176, between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday.", "product_quantity": "504 units total", "distribution_pattern": "Nationwide distribution to Georgia and Maryland.\n\nInternational distribution to Belgium, Germany, Finland, France, Greece, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United 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