BEUDAMED
    FDA Recall Terminated

    Model 8666 Washer/Disinfector with holding tank heater option. Firm on label is Getinge Disinfection AB, Vaxjo, Sweden.

    Recall: Z-0908-03 · Initiated March 25, 2003

    Recall

    Recall Number
    Z-0908-03
    Event Number
    26011
    Firm
    Getinge/Castle, Inc.
    FEI Number
    1314329
    Product Code
    MEC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 25, 2003
    Posted
    June 5, 2003
    Terminated
    January 14, 2004
    Address
    1777 E Henrietta Road, Rochester, NY, 14623

    Description

    Model 8666 Washer/Disinfector with holding tank heater option. Firm on label is Getinge Disinfection AB, Vaxjo, Sweden.

    Reason

    Hot water may splash from the washer chamber creating a burn hazard.

    Action

    Letter dated 3/25/03 flagged: ''Important Safety Alert/Product Upgrade''. Customers advised to discontinue use until the field correction is performed.

    Distribution

    Nationwide. Medical facilities in AL, CA, CO, LA, MA, MI, MN, MO, NC, NH, NM, OK, PA, TX, WA, and WI.

    Quantity

    75 units