BEUDAMED
    FDA Recall Terminated

    Pulmonary Hemi-Artery SG Used in heart surgery

    Recall: Z-1561-2011 · Initiated February 17, 2011

    Recall

    Recall Number
    Z-1561-2011
    Event Number
    57974
    Firm
    CryoLife, Inc.
    FEI Number
    3001451326
    Product Code
    DXZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 17, 2011
    Posted
    March 4, 2011
    Terminated
    April 24, 2012
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144-3632

    Description

    Pulmonary Hemi-Artery SG Used in heart surgery

    Reason

    Staphylococcus aureus (not methicillin resistant) identified in companion tissue.

    Action

    CryoLife Inc. issued a letter to the physician on February 17, 2011, advising him of the results of the testing performed on a companion cardiac allograft. The letter did not recommend explant of the allograft or special antimicrobial treatment of the patient unless medically necessary. The physician was asked to complete and return the enclosed, stamped, self-addressed postcard affirming the receipt of the notification. For any questions the physician was advised to call 770-419-3355.

    Distribution

    Nationwide Distribution including AZ & NV

    Quantity

    One