BEUDAMED
    FDA Enforcement Class II Terminated

    Extra corporeal circuit with bio-active surface.

    Recall: Z-2495-2020 · Reported July 15, 2020

    Enforcement

    Recall Number
    Z-2495-2020
    Event ID
    85821
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Perfusion Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 15, 2020
    Initiation Date
    August 8, 2018
    Classification Date
    July 4, 2020
    Termination Date
    October 6, 2020
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088, United States

    Description

    Extra corporeal circuit with bio-active surface.

    Reason

    Affected products failed a sterilization test.

    Code Info

    Lot# 215729283

    Distribution

    Domestic Distribution only to CA and MI.

    Quantity

    10 units