BEUDAMED
    FDA Enforcement Class II Terminated

    Norm-O-Temp model 111W

    Recall: Z-2356-2019 · Reported September 11, 2019

    Enforcement

    Recall Number
    Z-2356-2019
    Event ID
    83376
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cincinnati Sub-Zero Products LLC, a Gentherm Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 11, 2019
    Initiation Date
    June 20, 2019
    Classification Date
    September 4, 2019
    Termination Date
    June 9, 2020
    Address
    12011 Mosteller Rd, N/A, Cincinnati, OH, 45241-1528, United States

    Description

    Norm-O-Temp model 111W

    Reason

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

    Code Info

    Serial number Range: 091-N6669-192-N7901 UDI: 10613031861563, 10613031861570, 10613031861587, 10613031861617 Part # 86156, 86157,86158, 86161

    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

    1063