BEUDAMED
    FDA Recall Terminated

    Norm-O-Temp model 111Z

    Recall: Z-2355-2019 · Initiated June 20, 2019

    Recall

    Recall Number
    Z-2355-2019
    Event Number
    83376
    Firm
    Cincinnati Sub-Zero Products LLC, a Gentherm Company
    FEI Number
    1516825
    Product Code
    DWJ
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    June 20, 2019
    Terminated
    June 9, 2020
    Address
    12011 Mosteller Rd, Cincinnati, OH, 45241-1528

    Description

    Norm-O-Temp model 111Z

    Reason

    The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.

    Action

    1. Access updated manuals and ensure that obsolete manuals are removed from services. updated manuals may be accessed via www.gentherm.com or physical copies may be requested from Gentherm Medical, LLC at 1-888-437-5608 2. Inform the content of the notification to all users and if you have further distributed this product, please provide those account with a copy of this notice. 3. Please complete and return the enclosed response form as soon as receipt of this notification and to inform Gentherm Medical, LLC and return the form by e-mail to [email protected] or mail to : Gentherm Medical, LLC, 12011 Mosteller Road, Cincinnati, OH 45241. If you have any questions, call Gentherm Medical Technical Support at 1-888-437-5608.

    Distribution

    Ship-To State AL AR AZ CA CO CT DC DE FL GA HI IL IN KS KY LA MA MD ME MI MN MO NC ND NE NH NJ NM NY OH OK PA RI SC TN TW TX UT VA WA WI WV WY Ship-To Country United States Taiwan Egypt United Arab Emirates Israel Pakistan Turkey Colombia Thailand Kuwait United Kingdom Mexico Netherlands Canada Ecuador South Korea Germany Georgia China Panama Japan Malaysia Hong Kong Austria Chile Mongolia Morocco Australia Indonesia Venezuela Singapore

    Quantity

    674