BEUDAMED
    FDA Recall Terminated

    Avazzia Med-Sport Massager; Model: BEST AV-1; P/N #MS04182-103; manufactured by Avazzia, Inc., Dallas, TX 75240.

    Recall: Z-1210-2007 · Initiated June 29, 2007

    Recall

    Recall Number
    Z-1210-2007
    Event Number
    38308
    Firm
    Avazzia, Inc
    FEI Number
    3004839404
    Product Code
    GZJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 29, 2007
    Posted
    September 1, 2007
    Terminated
    April 4, 2008
    Address
    13154 Coit Rd, Ste 200, Dallas, TX, 75240-5787

    Description

    Avazzia Med-Sport Massager; Model: BEST AV-1; P/N #MS04182-103; manufactured by Avazzia, Inc., Dallas, TX 75240.

    Reason

    Plastic Cases may crack due to manufacturing by the supplier not meeting specifications

    Action

    Firm notified consignees by letter on June 29, 2007 requesting that all affected product be returned to the firm for repair or replacement. The firm further asked for distributors who had shipped affected product to notify receiving patients so they could arrange for repair or replacement.

    Distribution

    Nationwide including states of Texas, Pennsylvania, Louisiana, Wyoming, and California

    Quantity

    75 units