Z-0063-2019 Class II Terminated
FDA device recall Z-0063-2019 was initiated by Cincinnati Sub-Zero Products LLC, a Gentherm Company on September 4, 2018 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated May 23, 2019). Affected quantity: 270 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 10, 2018
- Initiation Date
- September 4, 2018
- Termination Date
- May 23, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 270 units
Product 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 for Recall
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.
Distribution Pattern
US Nationwide Distribution
Code Information
UDI 10613031860221