BEUDAMED
    FDA Enforcement Class II Terminated

    CryoPatch SG Pulmonary Hemi-Artery, 1 graft

    Recall: Z-0121-2019 · Reported October 24, 2018

    Enforcement

    Recall Number
    Z-0121-2019
    Event ID
    81095
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CryoLife, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    October 24, 2018
    Initiation Date
    September 6, 2018
    Classification Date
    October 17, 2018
    Termination Date
    March 3, 2020
    Address
    1655 Roberts Blvd Nw, N/A, Kennesaw, GA, 30144-3632, United States

    Description

    CryoPatch SG Pulmonary Hemi-Artery, 1 graft

    Reason

    The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The graft labeling indicates the conduit length is 1.0cm and the branch length is 4.5cm.

    Code Info

    Model Number SGPH00, Serial Number 10978889, Lot Number 144125, Expiration Date 05/16/2022

    Distribution

    US Nationwide in the state of California.

    Quantity

    1 graft