FDASeptember 4, 2018device
Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six ho...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential for membrane (control panel) switch errors leading to an inability of the device to change control settings or an unintended change to control settings.
What to do
FDA enforcement status: Terminated
Brands named
cincinnati sub zero products llc a genthermcincinnaticincinnati sub
UPCs
10613031860221
Recall history
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- FDAHydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T32026-04-24
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