BEUDAMED
    FDA Enforcement Class II Terminated

    Pulmonary Hemi-Artery SG Used in heart surgery

    Recall: Z-0809-2014 · Reported January 29, 2014

    Enforcement

    Recall Number
    Z-0809-2014
    Event ID
    67182
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CryoLife, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    January 29, 2014
    Initiation Date
    November 22, 2013
    Classification Date
    January 23, 2014
    Termination Date
    February 20, 2014
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144-3632, United States

    Description

    Pulmonary Hemi-Artery SG Used in heart surgery

    Reason

    Serological testing for the donor was performed with a blood sample that may have been hemodiluted due to the administration of normal saline to the donor prior to death.

    Code Info

    Serial No. 10119759, Model SGPH00

    Distribution

    US distribution in CA.

    Quantity

    One