BEUDAMED
    FDA Recall Terminated

    Merit Medical GmbH, Unomedical Ltd., Catheter Fixation Device StayFIX Fixation Device for Percutaneous Catheters Used to secure catheters in place without the use of sutures, reducing the exposure of sharps and sharp-related accidents.

    Recall: Z-0521-2010 · Initiated September 29, 2009

    Recall

    Recall Number
    Z-0521-2010
    Event Number
    53557
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    1721504
    Product Code
    KGZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 29, 2009
    Posted
    December 14, 2009
    Terminated
    December 15, 2009
    Address
    1600 Merit Pkwy South, Jordan, UT, 84095

    Description

    Merit Medical GmbH, Unomedical Ltd., Catheter Fixation Device StayFIX Fixation Device for Percutaneous Catheters Used to secure catheters in place without the use of sutures, reducing the exposure of sharps and sharp-related accidents.

    Reason

    Potential sterility breach caused by excessive shipment damage.

    Action

    Merit Medical Customers were contacted directly by phone and letter on 9/29/09. Customers were instructed to identify and quarantine all unused affected product. Further information was available at 801-208-4365.

    Distribution

    US (AL, LA, MO, KY, TN, GA). No military, government or foreign distribution.

    Quantity

    5 fixation devices