BEUDAMED
    FDA Enforcement Class II Terminated

    The Hemotherm 400CE 115v, containing power board p/n 39945

    Recall: Z-0654-2017 · Reported November 30, 2016

    Enforcement

    Recall Number
    Z-0654-2017
    Event ID
    75641
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cincinnati Sub-Zero Products Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 30, 2016
    Initiation Date
    November 7, 2016
    Classification Date
    November 22, 2016
    Termination Date
    February 22, 2017
    Address
    12011 Mosteller Rd, N/A, Cincinnati, OH, 45241-1528, United States

    Description

    The Hemotherm 400CE 115v, containing power board p/n 39945

    Reason

    The device may not maintain water flow or temperature control.

    Code Info

    154-10360CE 163-10502CE 163-10512CE 163-10527CE 164-10537CE 163-10491CE 163-10503CE 163-10513CE 163-10528CE 164-10538CE 163-10493CE 163-10504CE 163-10514CE 163-10529CE 164-10539CE 163-10495CE 163-10505CE 163-10515CE 163-10530CE 164-10540CE 163-10496CE 163-10506CE 163-10521CE 164-10531CE 164-10543CE 163-10497CE 163-10507CE 163-10522CE 164-10532CE 164-10544CE 163-10498CE 163-10508CE 163-10523CE 164-10533CE 164-10545CE 163-10499CE 163-10509CE 163-10524CE 164-10534CE 164-10547CE 163-10500CE 163-10510CE 163-10525CE 164-10535CE 164-10548CE 163-10501CE 163-10511CE 163-10526CE 164-10536CE 164-10549CE

    Distribution

    US Distribution to the states of : CA, FL, GA, MA, MN, NC, NJ, OH, PA and SC.

    Quantity

    50