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.

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.

On September 4, 2018, the firm, CSZ, issued an "Urgent Medical Device Correction" notices to customers overnight via courier service. Customers were advised to take the following actions: - Immediately examine your inventory and quarantine product subject to the field action. - If you choose to use the product prior to the correction, please consider having a backup device available. - In addition, if you have further distributed this product, please identify your customers and notify them at once of this medical device correction. Your notification to your customers may be enhanced by including a copy of the Urgent Medical Device Correction letter. - Contact CSZ Technical Support (1-888-437-5608) for a replacement kit: Reference FA2017-015 for the Hemotherm control panel kit or you may contact CSZ Technical Support to request replacement by a CSZ representative. - Once the replacement kit is received follow Hemotherm Control Panel Replacement Instructions provided in the kit. - Complete and return the response form provided to acknowledge receipt of the notification and to inform CSZ that customers have performed the requested actions via fax to (513) 772-9119 or via email to [email protected]. If you have any questions, call Kathy DeSmidt @ 513-772-8810.