FDA Enforcement
Class II
Terminated
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 hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper/hypothermia blanket under the patient to provide warming through conductive heat transfer.
Recall: Z-0063-2019
·
Reported October 10, 2018
Enforcement
- Recall Number
- Z-0063-2019
- Event ID
- 80941
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Cincinnati Sub-Zero Products LLC, a Gentherm Company
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 10, 2018
- Initiation Date
- September 4, 2018
- Classification Date
- October 3, 2018
- Termination Date
- May 23, 2019
- Address
- 12011 Mosteller Rd, Cincinnati, OH, 45241-1528, United States
Description
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 hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper/hypothermia blanket under the patient to provide warming through conductive heat transfer.
Reason
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.
Code Info
UDI 10613031860221
Distribution
US Nationwide Distribution
Quantity
270 units