BEUDAMED
    FDA Recall Terminated

    Psi Bands acupressure/acustimulation wrist bands in the following colors: Racer Black (UPC 859570001036), Daisy Chain (UPC 859570001029), Color Play (UPC 859570001043) and Cherry Blossom (UPC 859570001012).

    Recall: Z-1821-2008 · Initiated April 26, 2007

    Recall

    Recall Number
    Z-1821-2008
    Event Number
    48123
    Firm
    Psi Health Solutions
    FEI Number
    3006236731
    Product Code
    MVV
    Status
    Terminated
    Root Cause
    PMA
    Initiated
    April 26, 2007
    Posted
    September 2, 2008
    Terminated
    December 18, 2008
    Address
    1013 Morse Dr, Pacific Grove, CA, 93950-4912

    Description

    Psi Bands acupressure/acustimulation wrist bands in the following colors: Racer Black (UPC 859570001036), Daisy Chain (UPC 859570001029), Color Play (UPC 859570001043) and Cherry Blossom (UPC 859570001012).

    Reason

    Product was marketed before its 510(k) application cleared.

    Action

    Recall imitated 04/26/07. Retailers were informed via phone and email and mail. The product was marketed prior to the firm receiving clearance to market from the FDA. Contact Carla Falcone at 831-373-7712 if you have questions.

    Distribution

    Product was distributed to approximately 21,000 consumers and retailers throughout the US.

    Quantity

    21000 units