BEUDAMED
    FDA Enforcement Class II Terminated

    ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009; (b) Model 1010 Forced air dryer for medical devices

    Recall: Z-3034-2017 · Reported August 23, 2017

    Enforcement

    Recall Number
    Z-3034-2017
    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 1000 MEDICAL DEVICE DRYER: (a) Model 1009; (b) Model 1010 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: 191601, 191602, 191604, 191605, 19161, 191611, 191612, 191613, 191614, 191615, 191616 (b) Serial numbers: 101505, 101506, 101603, 101606, 101607, 101608, 101609

    Distribution

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

    Quantity

    18 units