BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1995-2014 · Initiated January 24, 2013

    Recall

    Recall Number
    Z-1995-2014
    Event Number
    68580
    Firm
    Cenorin, LLC
    FEI Number
    3004153171
    Product Code
    LDS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 24, 2013
    Posted
    July 6, 2014
    Terminated
    February 10, 2015
    Address
    6324 S 199th Pl, Ste 107, Kent, WA, 98032-2135

    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.

    Action

    Cenorin sent a Notification letter dated December 18, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated: Cenorin has developed an upgrade to mitigate this issue as well as provide additional process control and system monitoring benefits. Cenorin included a Return Response form with the recall letter to be completed and return. For questions contact HLD Systems Sales Representative for questions.

    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