BEUDAMED
    FDA Enforcement Class II Terminated

    S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.

    Recall: Z-0856-2014 · Reported February 5, 2014

    Enforcement

    Recall Number
    Z-0856-2014
    Event ID
    67199
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sorin Group Deutschland GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 5, 2014
    Initiation Date
    December 4, 2013
    Classification Date
    January 28, 2014
    Termination Date
    December 28, 2015
    Address
    Lindberghstrasse 25, Munchen, N/A, Germany

    Description

    S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.

    Reason

    Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to reports of pump speed control knob failures resulting in no response.

    Code Info

    S5 Item Number: 10-80-00, 10-85-00, 28-9S-80, 28-95-8S. C5 Item Number: S8-00-00

    Distribution

    Worldwide Distribution - US (Nationwide) and PR; and Internationally to:BE, ES, FI, GB, NL, SE, AR, AT, AU, CA, CH, CN, CR, EG, HK, ID, JO, JP, KR, KW, LB, LY, MM, PL, RO, RS, RU, SG. TH, TN, TR, TW, UA, VN, and ZA.

    Quantity

    323