BEUDAMED
    FDA Enforcement Class II Terminated

    CryoPatch SG Pulmonary Hemi-Artery Patch

    Recall: Z-1219-2019 · Reported May 1, 2019

    Enforcement

    Recall Number
    Z-1219-2019
    Event ID
    82380
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CryoLife, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 1, 2019
    Initiation Date
    November 21, 2016
    Classification Date
    April 25, 2019
    Termination Date
    September 24, 2019
    Address
    1655 Roberts Blvd Nw, N/A, Kennesaw, GA, 30144-3632, United States

    Description

    CryoPatch SG Pulmonary Hemi-Artery Patch

    Reason

    The device is recalled due to donor ineligibility of released human tissue. The firm received information that the tissue donor's blood culture tested positive for Enterobacter cloacae.

    Code Info

    Model #: SGPHOO Serial #10685466

    Distribution

    Product was shipped to Texas

    Quantity

    1