BEUDAMED
    FDA Recall Terminated

    One heart and pericardium from donor 12144.

    Recall: Z-0677-03 · Initiated August 20, 2002

    Recall

    Recall Number
    Z-0677-03
    Event Number
    25493
    Firm
    DCI Donor Services Tissue Services Division
    FEI Number
    1000307504
    Product Code
    MIE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 20, 2002
    Posted
    March 26, 2003
    Terminated
    April 8, 2003
    Address
    1714 Hayes Street, Nashville, TN, 37203

    Description

    One heart and pericardium from donor 12144.

    Reason

    Human tissue was procured from donor using non-sterile instruments.

    Action

    Consignee was notified by memorandum on 8/20/2002.

    Distribution

    GA

    Quantity

    One heart and pericardium.