BEUDAMED
    FDA Enforcement Class II Terminated

    Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO

    Recall: Z-2271-2018 · Reported June 27, 2018

    Enforcement

    Recall Number
    Z-2271-2018
    Event ID
    80199
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CryoLife, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 27, 2018
    Initiation Date
    May 14, 2018
    Classification Date
    June 21, 2018
    Termination Date
    March 29, 2019
    Address
    1655 Roberts Blvd NW, N/A, Kennesaw, GA, 30144-3632, United States

    Description

    Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO

    Reason

    Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.

    Code Info

    Serial Number 10988203

    Distribution

    AR, OH

    Quantity

    1 unit