BEUDAMED
    FDA Enforcement Class III Terminated

    LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs include the cuvette used with equipment to monitor blood.

    Recall: Z-1389-2020 · Reported March 4, 2020

    Enforcement

    Recall Number
    Z-1389-2020
    Event ID
    84732
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    LivaNova USA Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    March 4, 2020
    Initiation Date
    July 3, 2019
    Classification Date
    February 27, 2020
    Termination Date
    July 9, 2021
    Address
    14401 W 65th Way, N/A, Arvada, CO, 80004-3503, United States

    Description

    LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs include the cuvette used with equipment to monitor blood.

    Reason

    Perfusion tubing pack was packaged with the incorrect cuvette.

    Code Info

    Model Number: 046008200 Lot Number: 1912100141 UDI: (01)00803622140136(240)046008200 (17)210430(10)1912100141 Cuvette Component P/N 03016 - SAT/HCT B-care 5 cuvette

    Distribution

    US Nationwide distribution in the state of IL.

    Quantity

    27 packs