BEUDAMED
    FDA Recall Terminated

    IV Catheter - Optiva IV Catheter. This is found in box labeled 'Graft Jacket Xpress Flowable Soft Tissue Scaffold'; labeled by Wright.

    Recall: Z-0162-2011 · Initiated September 13, 2010

    Recall

    Recall Number
    Z-0162-2011
    Event Number
    56826
    Firm
    LifeCell Corporation
    FEI Number
    1000306051
    Product Code
    KGZ
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    September 13, 2010
    Posted
    October 28, 2010
    Terminated
    August 17, 2012
    Address
    1 Millennium Way, Somerville, NJ, 08876-3876

    Description

    IV Catheter - Optiva IV Catheter. This is found in box labeled 'Graft Jacket Xpress Flowable Soft Tissue Scaffold'; labeled by Wright.

    Reason

    Graft Jacket Xpress kits contain catheters that will expire or have already expired prior to the labeled expiration of the human tissue component of the product on the outer box.

    Action

    Lifecell Corporation, Branchburg, NJ initiated a recall to their distributor Wright Medical Technology, Arlington, TN on 9/13/2010.

    Distribution

    Nationwide Distribution: USA, to distributor in TN

    Quantity

    1507 kits