BEUDAMED
    FDA Recall Terminated

    Model ST-400 Solafeet Foot portable tanners; Solafeet, Inc. Use: feet tanner.

    Recall: Z-0608-2010 · Initiated September 8, 2009

    Recall

    Recall Number
    Z-0608-2010
    Event Number
    54226
    Firm
    Solafeet, Inc.
    FEI Number
    3007708365
    Product Code
    REG
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    September 8, 2009
    Posted
    February 16, 2010
    Terminated
    August 21, 2012
    Address
    W University Pkwy, Unit A, Sarasota, FL, 34243-2742

    Description

    Model ST-400 Solafeet Foot portable tanners; Solafeet, Inc. Use: feet tanner.

    Reason

    Product failed to have a label that contained a recommended exposure schedule; the operator's manual provided inadequate instructions for use; and label implication may result in overexposure.

    Action

    Solafeet sent letters to customers informing them that the labeling and instructions included with the product were not in accordance with the FDA requirements. Attached with the letter was a replacement label and a replacement set of instructions. Customers are to attach the new label on top of the old label and use the new instructions, noting the change in exposure limits. Questions should be directed to 941-359-2608 or [email protected].

    Distribution

    Nationwide Distribution

    Quantity

    72 units