BEUDAMED
    FDA Enforcement Class II Terminated

    ThermaSure(TM), a CENORIN(TM) product, SERIES 300 MEDICAL DEVICE DRYER: (a) Model 330; (b) Model 340 Forced air dryer for medical devices

    Recall: Z-3033-2017 · Reported August 23, 2017

    Enforcement

    Recall Number
    Z-3033-2017
    Event ID
    77637
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cenorin, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    August 23, 2017
    Initiation Date
    June 7, 2017
    Classification Date
    August 14, 2017
    Termination Date
    May 2, 2018
    Address
    6324 S 199th Pl, Suite 107, Kent, WA, 98032, United States

    Description

    ThermaSure(TM), a CENORIN(TM) product, SERIES 300 MEDICAL DEVICE DRYER: (a) Model 330; (b) Model 340 Forced air dryer for medical devices

    Reason

    Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn.

    Code Info

    (a) Serial Numbers: 331517, 331518, 331523, 331524, 331525, 331526, 331527, 331528, 331529, 331530, 331601, 331608, 331609, 331612, 331615, 331616, 331621, 331622, 331623, 331624, 331625, 331626, 331627 (b) Serial numbers: 341506, 341507, 341516, 341520, 341521, 341522, 341602, 341603, 341604, 341605, 341606, 341607, 341610, 341611, 341613, 341614, 341617, 341618, 341619, 341620

    Distribution

    Worldwide Distribution - US (Nationwide) Internationally to Japan, Hong Kong, Brunei, and Israel

    Quantity

    43 units