BEUDAMED
    FDA Enforcement Class II Terminated

    HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.

    Recall: Z-1995-2014 · Reported July 16, 2014

    Enforcement

    Recall Number
    Z-1995-2014
    Event ID
    68580
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cenorin, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 16, 2014
    Initiation Date
    January 24, 2013
    Classification Date
    July 6, 2014
    Termination Date
    February 10, 2015
    Address
    6324 S 199th Pl Ste 107, Kent, WA, 98032-2135, United States

    Description

    HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.

    Reason

    The temperature sensor/control system in the HLD Systems Model 610 may provide a false temperature reading. This caused the water to remain at ambient temperature throughout the pasteurization cycle rather than using hot water.

    Code Info

    610601, 610603, 610703, 610704, 610705, 610707, 610708, 610802, 610803, 610804, 610901, 610903, 610904, 610905, 611001, 611002, 611004, 611101, 611102, 611103, 611201, 611202, 611203, 610902L, 611204.

    Distribution

    Worldwide Distribution - US (nationwide): CA, DE, FL, MA, MI, NY, PA, TX, UT, WA, and WI and the countries of Uruguay and Taiwan.

    Quantity

    25 HLD systems