BEUDAMED
    FDA Enforcement Class II Terminated

    115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165.

    Recall: Z-1679-2014 · Reported June 11, 2014

    Enforcement

    Recall Number
    Z-1679-2014
    Event ID
    68356
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cincinnati Sub-Zero Products Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    June 11, 2014
    Initiation Date
    January 8, 2014
    Classification Date
    June 2, 2014
    Termination Date
    June 6, 2014
    Address
    12011 Mosteller Rd, Cincinnati, OH, 45241-1528, United States

    Description

    115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165.

    Reason

    The incorrect voltage component was placed into the device during manufacturing. This may make the device unable to maintain patient temperature during cooling mode. The device will continue to indicate that the unit is cooling because the compressor will continue to run, however water in the reservoir will begin to return to ambient temperature. The actual water temperature will be displayed but

    Code Info

    Model Number 222S; Serial #s: 133-2-00697, 133-2-00698; 133-2-00699; 133-2-00700; 133-2-00701; 133-2-00702; and 133-2-00703:.Part # 86165

    Distribution

    The product was distributed to one customer in MI, and internationally (Taiwan)

    Quantity

    7 units