BEUDAMED
    FDA Enforcement Class II Terminated

    HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610HT, 115V & Model 610HT, 230V Product Usage: Clean and thermally disinfect medical devices using full immersion pasteurization

    Recall: Z-2288-2018 · Reported July 4, 2018

    Enforcement

    Recall Number
    Z-2288-2018
    Event ID
    80295
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cenorin, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 4, 2018
    Initiation Date
    April 9, 2018
    Classification Date
    June 26, 2018
    Termination Date
    September 13, 2019
    Address
    6324 S 199th Pl, Suite 107, Kent, WA, 98032, United States

    Description

    HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610HT, 115V & Model 610HT, 230V Product Usage: Clean and thermally disinfect medical devices using full immersion pasteurization

    Reason

    There is a supplier quality issue with the terminal blocks which may cause the terminal block to overheat, char and/or burn.

    Code Info

    Serial Numbers: 611503, 611504, 611505, 611506, 611601, 611602, 611603, 611604, 611605, 611606, 611607, 611608, 611609 & 611610

    Distribution

    Worldwide Distribution - US Nationwide in the states of CA, FL, IN, NC, NE, UT & WV; and countries of Malaysia and Taiwan

    Quantity

    14 units