BEUDAMED
    FDA Recall 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 · Initiated April 9, 2018

    Recall

    Recall Number
    Z-2288-2018
    Event Number
    80295
    Firm
    Cenorin, LLC
    FEI Number
    3004153171
    Product Code
    LDS
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 9, 2018
    Terminated
    September 13, 2019
    Address
    6324 S 199th Pl, Suite 107, Kent, WA, 98032

    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.

    Action

    On April 9, 2018, Cenorin telephoned customers and then followed-up with a formal letter titled URGENT MEDICAL DEVICE RECALL via email. To mitigate this quality issue, Cenorin has a Corrective Kit available to replace the existing terminal blocks in the Washer/Pasteurizer as the long-term solution. In the meantime, here is how you can help with the recall process: 1. Please immediately examine your inventory for the recalled Washer/Pasteurizers listed and quarantine them to prevent further distribution. In addition, if you have further distributed this product, please notify your customers immediately using the enclosed notice. 2. If the Washer/Pasteurizers does not exhibit any of the symptoms of failure as noted, continue to use the Washer/Pasteurizers as normal until the service can be completed. If the Washer/Pasteurizers exhibit any of the symptoms of failure, immediately cease its use and contact Cenorin immediately at [email protected] or call Technical Support at 800-426-1042 ext. 224. 3. Complete the Recall Acknowledgement & Response Form and return to Cenorin as noted on form via email to [email protected] within 5 business days. Response is required. Customers with questions, please email Cenorin at [email protected] or call 253-395-2400 or toll-free 800-426-1042, extension 236 during the hours of business Monday through Friday, 7:30AM to 4:30PM, Pacific Standard Time.

    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