BEUDAMED
    FDA Recall Terminated

    Therakos Photopheresis Procedural Kit for use with the UVAR XTS Instrument. (catalog number XT125)

    Recall: Z-1504-06 · Initiated July 18, 2006

    Recall

    Recall Number
    Z-1504-06
    Event Number
    35894
    Firm
    Therakos Inc
    FEI Number
    2523595
    Product Code
    LNR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 18, 2006
    Posted
    September 14, 2006
    Terminated
    June 19, 2007
    Address
    429 Creamery Way, Exton, PA, 19341-2508

    Description

    Therakos Photopheresis Procedural Kit for use with the UVAR XTS Instrument. (catalog number XT125)

    Reason

    Centrifuge Bowl may leak

    Action

    The recalling firm sent a recall letter dated 7/18/06 to their customers informing them of the problem. The letter gave instructions for continued use until new kits are available.

    Distribution

    Nationwide (including AL, AR, AZ, CA, CO, FL, GA, IL, MA, MD, MI, MO, NE, NJ, NY, OK, OR, PA, TN, TX, UT, VA, WA, and WI). Worldwide, including France, Cyprus, Hungary, Saudi Arabia, Singapore, United Kingdom, Austria, Germany, Norway, Italy, Turkey and Portugal.

    Quantity

    1315 units