TherMax Blood Warmer Unit
Check against the official notice below — it lists the full affected range.
Baxter Healthcare Corporation is recalling TherMax Blood Warmer units because they may not meet an electrical safety standard requiring a protective earth connection capable of sustaining 25 amps of current for 10 seconds. A total of 504 units are affected, distributed in Georgia and Maryland within the United States, as well as internationally to Belgium, Germany, Finland, France, Greece, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, the United Kingdom, Australia, and New Zealand.
The recalled units include two product codes: 955630 (with multiple specific serial numbers) and 955515 (with numerous specific serial numbers). The source document does not specify what action affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: 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 Quantity: 504 units total Lot/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, 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, 1007
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.