BEUDAMED
    FDA Enforcement Class III Terminated

    Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO.

    Recall: Z-0664-2018 · Reported February 28, 2018

    Enforcement

    Recall Number
    Z-0664-2018
    Event ID
    79000
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    LivaNova USA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 28, 2018
    Initiation Date
    December 19, 2017
    Classification Date
    February 21, 2018
    Termination Date
    August 11, 2020
    Address
    14401 W 65th Way, N/A, Arvada, CO, 80004-3503, United States

    Description

    Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO.

    Reason

    The product is labeled with the incorrect expiration date.

    Code Info

    Lot 1717800062, UDI (01)00803622108075(240)088511400(17)190630(10)1717800082; and Lot 1720800071, UDI (01)00803622108075(240)088511400(17)190731(10)1720800071

    Distribution

    Distribution was made to one consignee in LA.

    Quantity

    16 units (6 from lot 1717800062 and 10 units from lot 1720800071