BEUDAMED
    FDA Recall Terminated

    Game Ready Professional Therapy System, a cryotherapy device. Intended to treat postsurgical and acute injuries to reduce edema, swelling and pain where indicated.

    Recall: Z-3210-2011 · Initiated August 23, 2011

    Recall

    Recall Number
    Z-3210-2011
    Event Number
    59826
    Firm
    CoolSystems, Inc.
    FEI Number
    3003186150
    Product Code
    IRP
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    August 23, 2011
    Posted
    September 14, 2011
    Terminated
    November 14, 2011
    Address
    1201 Marina Village Pkwy, Suite 200, Alameda, CA, 94501-1087

    Description

    Game Ready Professional Therapy System, a cryotherapy device. Intended to treat postsurgical and acute injuries to reduce edema, swelling and pain where indicated.

    Reason

    It was discovered that some Game Ready Professional Therapy System units that were to have been quarantined pending final inspection and testing were inadvertently moved to finished goods inventory and shipped.

    Action

    The firm, CoolSystems, Inc., contacted customers by phone on August 23, 2011. The customers were informed that some Game Ready Professional Therapy System units have been quarantined pending final inspection and testing were inadvertently moved to finished goods inventory and shipped. Instructions were given to immediately cease fulfilling orders from that inventory. Loaners were shipped to the customers overnight. The customers were instructed to replace the shipped device with the loaner that was sent and return it to the company ASAP. If you have any questions, contact the Vice President, Quality Assurance and Regulatory/Clinical Affairs at 510-868-5378.

    Distribution

    Nationwide distribution: CA, MA, MO, NH, OH, TX, UT, and WA.

    Quantity

    26 units