BEUDAMED
    FDA Recall 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 · Initiated September 4, 2018

    Recall

    Recall Number
    Z-0063-2019
    Event Number
    80941
    Firm
    Cincinnati Sub-Zero Products LLC, a Gentherm Company
    FEI Number
    1516825
    Product Code
    DWC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 4, 2018
    Posted
    October 3, 2018
    Terminated
    May 23, 2019
    Address
    12011 Mosteller Rd, Cincinnati, OH, 45241-1528

    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.

    Action

    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.

    Distribution

    US Nationwide Distribution

    Quantity

    270 units