BEUDAMED
    FDA Recall Terminated

    SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping through cardiopulmonary bypass circuit for typical durations of six hours or less.

    Recall: Z-0166-2013 · Initiated September 20, 2012

    Recall

    Recall Number
    Z-0166-2013
    Event Number
    63381
    Firm
    Sorin Group USA, Inc.
    FEI Number
    1718850
    Product Code
    DWA
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    September 20, 2012
    Posted
    October 29, 2012
    Terminated
    January 28, 2013
    Address
    14401 W 65th Way, Arvada, CO, 80004

    Description

    SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping through cardiopulmonary bypass circuit for typical durations of six hours or less.

    Reason

    Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Stockert Centrifugal Pump (SCP) Pump Control Panel . An out of specification circuit board component within the Panel may lead to a malfunction consisting of a blank or flashing display. The flow and pressure display information may also be incorrect after the malfunction.

    Action

    The firm, Sorin Group USA, Inc., sent an "URGENT FIELD SAFETY NOTICE" dated September 20, 2012 to all affected customers by certified mail. The notice described the product, problem and actions to be taken. Customers were instructed to discontinue use of and segregate affected product for return and replacement to the firm; to complete and return the attached Customer Response Form via fax to: 303-467-6502 or email to: [email protected]; and if they have transferred the affected products to a third party, to pass this information to the Sorin Group. Further questions may be directed to Sorin Group Customer Service at 1-800-650-2623.

    Distribution

    Worldwide distribution: USA (nationwide) including states of : MI and NY; and countries of: Belgium, Canada, Japan, India, Russia, United Arab Emirates.

    Quantity

    12 units (3 units USA and 9 units OUS)