BEUDAMED
    FDA Recall Terminated

    CPS Aim, Models 410140, 410141, 410142, 410144, 410145, 410146, 410147, & 410148

    Recall: Z-1167-06 · Initiated June 1, 2006

    Recall

    Recall Number
    Z-1167-06
    Event Number
    35616
    Firm
    St Jude Medical CRMD
    FEI Number
    2017865
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 1, 2006
    Posted
    June 24, 2006
    Terminated
    March 26, 2012
    Address
    15900 Valley View Ct, Sylmar, CA, 91342-3577

    Description

    CPS Aim, Models 410140, 410141, 410142, 410144, 410145, 410146, 410147, & 410148

    Reason

    Sterility-Some of the sterile pouches in which these products are packaged may not have been properly sealed during their packaging process.

    Action

    The attached 'Dear Hospital Administrator' letter was sent out to our US sales representatives via FedEx on June 1, 2006. The sales representatives have been instructed to send back all of the devices in their inventory and to retrieve and return any remaining devices that were placed into hospital inventory. They are also instructed to deliver the attached 'Dear Hospital Administrator' letter to the appropriate person at each hospital where product is to be removed from the hospital shelf.

    Distribution

    Hospitals/Medical Centers in AZ, CA, MS, NY, & PA

    Quantity

    4958