BEUDAMED
    FDA Enforcement Class II Terminated

    S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less.

    Recall: Z-0142-2014 · Reported November 13, 2013

    Enforcement

    Recall Number
    Z-0142-2014
    Event ID
    66464
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sorin Group Deutschland GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 13, 2013
    Initiation Date
    September 24, 2013
    Classification Date
    November 4, 2013
    Termination Date
    July 10, 2014
    Address
    Lindberghstrasse 25, N/A, Munchen, N/A, N/A, Germany

    Description

    S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less.

    Reason

    Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.

    Code Info

    Serial Numbers: 48E00235,48E00339,48E00342,48E01753,48E02767,48E02753,48E02745,48E02746,48E02748,48E02416,48E01033,480E1038,48E01040,48E01041,48E01043,48E01044,48E01051,48E02631,48E01183,48E02758,48E02764,48E01832,48E01834,48E02278,48E02722,48E02732,48E02326,48E02797,48E02793,48E02791,48E02781,48E02785,48E02786,48E02783,48E02772,48E02802,48E02778,48E02784,48E02788,48E02789,48E02779,48E02792,48E02790,48E02771,48E02773,48E02776,48E02799,48E02801

    Distribution

    Worldwide Distribution - USA including WA, NY, VA, TN, SC, TX, CA, CO, MA, WI, MD, AL, ND, and Puerto Rico and Internationally to Italy, Finland, Germany, Sweden, and Great Britain.

    Quantity

    84