BEUDAMED
    FDA Recall 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 · Initiated December 19, 2017

    Recall

    Recall Number
    Z-0664-2018
    Event Number
    79000
    Firm
    LivaNova USA
    FEI Number
    1718850
    Product Code
    DWE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 19, 2017
    Terminated
    August 11, 2020
    Address
    14401 W 65th Way, Arvada, CO, 80004-3503

    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.

    Action

    The recalling firm issued a letter dated 12/7/2017 via email on 12/19/2017.

    Distribution

    Distribution was made to one consignee in LA.

    Quantity

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