Hemotherm 400CE, Catalog Numbers 86022 & 86023 recallZ-0063-2019 · Cincinnati Sub-Zero Products LLC, a Gentherm Company · initiated Sep 4, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cincinnati Sub-Zero Products LLC, a Gentherm Company or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0063-2019
- Status
- Terminated
- Initiated by the company
- Sep 4, 2018
- Posted by the FDA
- Oct 3, 2018
- Recalling firm
- Cincinnati Sub-Zero Products LLC, a Gentherm Company
- Quantity
- 270 units
- Product code
- DWC
- FDA submissions
- K122813
- Distribution
- US Nationwide Distribution
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.
Code information (models, lots, serial numbers)
UDI 10613031860221
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Hemotherm 400CEGentherm Medical, LLC · Controller, Temperature, Cardiopulmonary Bypass1 recall30 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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