Baxter Healthcare Corporation: TherMax Blood Warmer Unit

Recall number

Z-0247-2020

Recalling firm

Baxter Healthcare Corporation

Product

TherMax Blood Warmer Unit

Status

Terminated

Initiated

2019-09-19

Posted

2019-10-30

Terminated

2020-12-11

Reason

TherMax Blood Warmers 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.

Root cause

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. Instructions 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. For 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.

Quantity

504 units total

Distribution

Nationwide distribution to Georgia and Maryland. International distribution to Belgium, Germany, Finland, France, Greece, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom, Australia, and New Zealand

Lot, serial or model codes

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, 100298, 100299, 100306, 100307, 100308, 100309, 100310, 100312, 100313, 100314, 100315, 100321, 100322, 100323, 100324, 100325, 100326, 100327, 100328, 100330, 100341, 100342, 100343, 100344, 100345, 100346, 100347, 100348, 100349, 100356, 100357, 100358, 100359, 100360, 100361, 100362, 100363, 100364, 100365, 100366, 100367, 100368, 100369, 100370, 100391, 100392, 100393, 100395, 100396, 100397,  100398, 100399, 100400, 100401, 100402, 100403, 100404, 100405, 100416, 100417, 100418, 100419, 100420, 100421, 100422, 100423, 100424, 100427, 100428, 100429, 100446, 100450, 100453, 100454, 100455, 100456, 100458, 100459, 100460, 100486, 100487, 100489, 100490, 100496, 100497, 100498, 100499, 100500, 100501, 100502, 100503, 100504, 100505, 100532, 100533, 100535, 100537, 100538, 100539, 100540, 100541, 100545, 100548, 100550, 100551, 100552, 100555, 100581, 100582, 100583, 100584, 100585, 100586, 100587, 100590, 100591, 100595, 100596, 100599, 100601, 100602, 100603, 100605, 100631, 100632, 100633, 100639, 100640, 100641, 100642, 100643, 100644, 100645, 100646, 100649, 100650, 100652, 100653, 100654, 100655, 100756, 100757, 100758, 100759, 100761, 100762, 100763, 100764, 100765, 100766, 100767, 100768, 100769, 100770, 100771, 100772, 100773, 100774, 100775, 100776, 100777, 100778, 100779, 100780, 100781, 100782, 100783, 100784, 100785, 100786, 100787, 100788, 100789, 100790, 100791, 100793, 100794, 100795, 100796, 100798, 100799, 100800, 100801, 100802, 100803, 100804, 100805, 100806, 100807, 100808, 100810, 100811, 100812, 100813, 100814, 100815, 100816, 100817, 100818, 100819, 100820, 100821, 100822, 100823, 100825, 100826, 100827, 100829, 100830, 100856, 100857, 100858, 100859, 100860, 100861, 100863, 100864, 100865, 100868, 100869, 100871, 100872, 100874, 100875, 100878, 100879, 100880, 100881, 100882, 100883, 100884, 100885, 100886, 100887, 100888, 100889, 100890, 100891, 100892, 100893, 100894, 100895, 100896, 100897, 100898, 100899, 100900, 100931, 100932, 100933, 100934, 100936, 100938, 100939, 100940, 100941, 100942, 100943, 100945, 100946, 100947, 100948, 100949, 100950, 100952, 100954, 100955, 100981, 100983, 100984, 100985, 100986, 100987, 100988, 100989, 100990, 100991, 100992, 100997, 100998, 100999, 101000, 101001, 101002, 101003, 101004, 101005, 101006, 101007, 101008, 101009, 101010, 101011, 101012, 101013, 101014, 101015, 101016, 101017, 101018, 101019, 101020, 101021, 101022, 101024, 101026, 101027, 101030, 101081, 101082, 101083, 101084, 101085, 101086, 101088, 101089, 101090, 101091, 101092, 101094, 101095, 101096, 101097, 101098, 101099, 101101, 101103, 101104, 101105, 101106, 101107, 101108, 101109, 101110, 101111, 101112, 101115, 101121, 101122, 101123, 101124, 101126, 101127, 101172, 101173, 101174, 101175, 101176, 101177, 101179, 101180, 101181, 101182, 101183, 101184, 101185, 101186, 101187, 101188, 101189, 101190, 101192, 101229, 101230, 101231, 101233, 101235, 101236, 101237, 101241, 101246, 101247, 101248, 101249, 101250, 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.

510(k) numbers

["K190910"]

PMA numbers

not on file

Product code

KDI

Firm FEI

1417572

Firm city

Deerfield

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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