FDAFDA · Alimentos y medicamentos·N.º oficial Z-0247-2020
TherMax Blood Warmer Unit
Publicado el 6 de noviembre de 2019 · Inicio del retiro: 19 de septiembre de 2019
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Baxter Healthcare Corporation
- Distribuidor
- 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
- Lote
- 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, 1
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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