BEUDAMED
    FDA Recall Terminated

    Smart Perfusion Pack, REF: 088502200, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004 Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.

    Recall: Z-1091-2010 · Initiated December 30, 2009

    Recall

    Recall Number
    Z-1091-2010
    Event Number
    54250
    Firm
    Sorin Group USA, Inc.
    FEI Number
    1718850
    Product Code
    DWF
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    December 30, 2009
    Posted
    March 12, 2010
    Terminated
    March 15, 2010
    Address
    14401 W 65th Way, Arvada, CO, 80004

    Description

    Smart Perfusion Pack, REF: 088502200, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004 Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.

    Reason

    Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.

    Action

    Customers were notified by letter on December 30, 2009 and asked to examine all inventory for seal voids and arrange for return if any were found defective. Examination instructions were included. The two distributors were given the same instructions and were told to share all the information with any of their customers.

    Distribution

    AZ, CA, FL, MO, NJ, SC, SD, TN, TX, UT, VA and WI.

    Quantity

    16 units