Z-0247-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 6, 2019
- Initiation Date
- September 19, 2019
- Termination Date
- December 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.