BEUDAMED
    FDA Enforcement Class II Terminated

    ThermaSure(TM), a CENORIN(TM) product, SERIES 130 MEDICAL DEVICE DRYER: (a) Model 135; (b) Model 136 Forced air dryer for medical devices

    Recall: Z-3032-2017 · Reported August 23, 2017

    Enforcement

    Recall Number
    Z-3032-2017
    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 130 MEDICAL DEVICE DRYER: (a) Model 135; (b) Model 136 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: 350423, 350424, 351506, 351507, 351512, 351513, 351514, 351516, 351602, 351604, 351605, 351606, 351609, 351611, 351613, 351614, 351615, 351616, 351617, 351618, 351619, 351620, 351621, 351622, 351623, 351624 (b) Serial numbers: 361505, 361511, 361515, 361601, 361603, 361607, 361608, 361612

    Distribution

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

    Quantity

    34 units