BEUDAMED
    FDA Recall Terminated

    Hemotherm Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circulating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the blood that enters and exits a blood heat exchanger for adult, pediatric or infant patients.

    Recall: Z-0629-2018 · Initiated November 27, 2017

    Recall

    Recall Number
    Z-0629-2018
    Event Number
    78173
    Firm
    Cincinnati Sub-Zero Products LLC
    FEI Number
    1516825
    Product Code
    DWC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 27, 2017
    Posted
    February 13, 2018
    Terminated
    July 2, 2018
    Address
    12011 Mosteller Rd, Cincinnati, OH, 45241-1528

    Description

    Hemotherm Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circulating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the blood that enters and exits a blood heat exchanger for adult, pediatric or infant patients.

    Reason

    Due to FDA's safety communication relating to nontuberculous mycobacteria (NTM) infections related to heater/cooler devices, an updated Instructions For Use includes a more robust cleaning & disinfection procedure.

    Action

    Between November 27, 2017 - December 8, 2017, Cincinnati Sub-Zero Products LLC, distributed Urgent Medical Device Correction notices to their customers via Email and USPS. This Medical Device Correction has been initiated to provide a labeling update to the cleaning & disinfection procedures. The update addresses the disinfection process, cleaning of reusable accessories, as well as clarifying the water type that should be used with the Hemotherm. Customers are encouraged to do the following: 1) Discard your current Hemotherm Operation & Technical Manual and/or Operation Manual. 2) Replace your current Hemotherm Operation & Technical Manual and/or Operation Manual with the enclosed updated Manual(s). For your convenience, all updates have been highlighted in the manuals. " For Hemotherm 400CE users, utilize the P/N 56418-R Operation & Technical Manual and P/N 56075-G Operation Manuals. " For Hemotherm 400MR users, utilize the P/N 56234-S Operation Manual. All customers are encouraged to complete and return the enclosed response form by fax or email to [email protected]; Fax: 513-772-9119. Customers with questions or concerns, please contact the Field Action Coordinator: Kathy DeSmidt, E-mail: [email protected], Phone: 513-772-8810 or 800-989-7373.

    Distribution

    US Nationwide Distribution

    Quantity

    1355 units