BEUDAMED
    FDA Enforcement Class III Terminated

    LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case

    Recall: Z-2642-2020 · Reported July 29, 2020

    Enforcement

    Recall Number
    Z-2642-2020
    Event ID
    85858
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    LivaNova USA Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 29, 2020
    Initiation Date
    November 18, 2019
    Classification Date
    July 17, 2020
    Termination Date
    August 19, 2021
    Address
    14401 W 65th Way, N/A, Arvada, CO, 80004-3503, United States

    Description

    LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case

    Reason

    Some packages of sterile disposable connectors contained a 3/8x1/4 reducer instead of the specified 1/2x1/2 connector. No significant risk to health is expected as the issue is easily detectable and the different shape would prevent use of the connector.

    Code Info

    Item# EC2135S, Lot No. 1923900091

    Distribution

    Distributed to medical facilities in 5 states including: Minnesota, Kansas, Missouri, Utah and Washington.

    Quantity

    140 units