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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 4 of 4 Results
510(K) Number: K031544
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Product Description
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Recall
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FDA Recall
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Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat e... 2 07/23/2021 Maquet Medical Systems USA
Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water ... 2 11/03/2016 Maquet Cardiovascular Us Sales, Llc
Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W Product Usage: The He... 2 01/05/2016 Maquet Cardiovascular Us Sales, Llc
Jostra Heater Cooler Unit HCU30, system version 1.02-Low voltage machine 2 01/25/2007 MAQUET Inc.
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