BEUDAMED
    FDA Recall Terminated

    Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.

    Recall: Z-0275-2013 · Initiated September 19, 2012

    Recall

    Recall Number
    Z-0275-2013
    Event Number
    63383
    Firm
    Sorin Group USA, Inc.
    FEI Number
    1718850
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    September 19, 2012
    Posted
    November 8, 2012
    Terminated
    January 18, 2013
    Address
    14401 W 65th Way, Arvada, CO, 80004

    Description

    Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.

    Reason

    Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determin

    Action

    The firm, Sorin Group, sent an "URGENT FIELD SAFETY NOTICE" dated September 19, 2012 to all affected customers by certified mail. The notice described the product, problem and actions to be taken. The customers were instructed to follow the provided instructions for the continued safe use of the Perfusion systems until they have been serviced or replaced by Sorin Group. The Sorin Group Service Team will contact the customer to schedule servicing and replacement of the affected product. The customers were also instructed to complete and return the Customer Response Form via fax to 303-467-6502 or by email to [email protected]; assure this notice is distributed to all personnel who need to be aware of this notice; and if they have transferred the affected products to a third party, pass this information with them as well as with Sorin Group Customer Service at 1-800-650-2623. For questions regarding this notice, contact Sorin Group USA Customer Service at 1-800-650-2623.

    Distribution

    Worldwide distribution: USA (nationwide) including states of: AZ, GA, MI, MS, NC, NY, PA, SC, and TX; and countries of: Austria, Australia, Belgium, Canada, People's Republic of China, Columbia, Denmark, Finland, Germany, India, Iran-Islamic Republic of, Ireland, Japan, Lebanon, Morocco, Pakistan, Poland, Russian Federation, Saudia Arabia, Spain, South Africa, Thailand, Turkey and United Kingdom.

    Quantity

    2 units (no product distributed within the US).