BEUDAMED
    FDA Recall Terminated

    HLD Systems Model 610 Washer/High Level Disinfector. Maximum weight of the Model 610 when filled with water is approximately 450 pounds. The dimensions of the system are: Width: 26.5" (67 cm); Depth: 33" (83 cm); Height: 46.5" (118 cm) to top of control panel; 64" (162.6 cm)- height clearance with lid open. Product Usage: Usage: This device washes reusable medical devices and disinfects them with high temperature hot water (pasteurization). The devices are washed with a cleaning solution (containing NaClO (sodium hypochlorite), surfactants, and detergents) to aid in the removal of debris and visible stains. Next, the medical devices and rinsed two times with water. The final, disinfection step uses only hot water at 160 F 2 F for 30 minutes.

    Recall: Z-1729-2014 · Initiated April 24, 2014

    Recall

    Recall Number
    Z-1729-2014
    Event Number
    68237
    Firm
    Cenorin, LLC
    FEI Number
    3004153171
    Product Code
    LDS
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    April 24, 2014
    Posted
    June 6, 2014
    Terminated
    June 30, 2015
    Address
    6324 S 199th Pl, Ste 107, Kent, WA, 98032-2135

    Description

    HLD Systems Model 610 Washer/High Level Disinfector. Maximum weight of the Model 610 when filled with water is approximately 450 pounds. The dimensions of the system are: Width: 26.5" (67 cm); Depth: 33" (83 cm); Height: 46.5" (118 cm) to top of control panel; 64" (162.6 cm)- height clearance with lid open. Product Usage: Usage: This device washes reusable medical devices and disinfects them with high temperature hot water (pasteurization). The devices are washed with a cleaning solution (containing NaClO (sodium hypochlorite), surfactants, and detergents) to aid in the removal of debris and visible stains. Next, the medical devices and rinsed two times with water. The final, disinfection step uses only hot water at 160 F 2 F for 30 minutes.

    Reason

    Cenorin LLC is voluntarily recalling HLD Systems Model 610 Washer/High Level Disinfector due to a potential risk of the system not injecting the proper amount of cleaning fluid during the wash cycle and not achieving the desired level of debris reduction.

    Action

    Cenorin sent a letter on April 24, 2014 informing their customers of the potential failure of the pump. This letter also explains the customer's option of upgrading their entire HLD System to the new cleaning fluid delivery system or to continue purchasing a six month PM kit that has a replacement pump added. Customers are instructed to complete and return an enclosed response form within 15 days and to email Jamie Wright at [email protected] or call 800-426-1042, extension 224 for questions.

    Distribution

    Distribution USA Nationwide

    Quantity

    25 HLD systems