Z-0247-2020 Class II Terminated
FDA device recall Z-0247-2020 was initiated by Baxter Healthcare Corporation on Sep 19, 2019 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated Dec 11, 2020). Affected quantity: 504 units total.
Recall details
- Product Type
- Devices
- Report Date
- Nov 6, 2019
- Initiation Date
- Sep 19, 2019
- Termination Date
- Dec 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 504 units total
Product description
TherMax Blood Warmer Unit
Reason for recall
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.
Distribution pattern
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
Code information
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0247-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026