BEUDAMED
    FDA Recall Terminated

    CryoPatch SG Pulmonary Hemi-Artery, 1 graft

    Recall: Z-0121-2019 · Initiated September 6, 2018

    Recall

    Recall Number
    Z-0121-2019
    Event Number
    81095
    Firm
    CryoLife, Inc.
    FEI Number
    3001451326
    Product Code
    DXZ
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    September 6, 2018
    Terminated
    March 3, 2020
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144-3632

    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.

    Action

    A formal recall notice was not sent to the customer involved. The customer complaint was followed up on and the affected graft returned prior to the initiation of the recall for investigation.

    Distribution

    US Nationwide in the state of California.

    Quantity

    1 graft