BEUDAMED
    FDA Recall 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 · Initiated January 8, 2014

    Recall

    Recall Number
    Z-1679-2014
    Event Number
    68356
    Firm
    Cincinnati Sub-Zero Products Inc
    FEI Number
    1516825
    Product Code
    DWJ
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    January 8, 2014
    Posted
    June 10, 2014
    Terminated
    June 6, 2014
    Address
    12011 Mosteller Rd, Cincinnati, OH, 45241-1528

    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

    Action

    The firm initiated a telephone notification on 01/08/2014, followed by a written notification which was sent to the customers via letter or email on 01/31/2014. URGENT Medical Device Field Action (January 31, 2014) REF: 115V Blanketrol II Model 22S Hyper-Hypothermia System (1) Discontinue Use and contact CSZ (2)Upon receipt of new 115V (p/n 91113) solenoid coil(s), immediately remove and destroy/discard all the affected 220V (p/n 3600) solenoid coil(s) (3)After the affected 220V (p/n 36007) solenoid coil(s) have been removed, discard and replaced, please complete and return the enclosed response form as soon as possible to acknowledge receipt of this notification and to imform CSZ that you have performed and completed the requested actions. Return the form by fax

    Distribution

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

    Quantity

    7 units