BEUDAMED
    FDA Recall Terminated

    StayFix Fixation Device for Percutaneous catheters, REF 685ME, (large) 12F - 22F, Merit Medical, Unomedical, Ltd., Great Britain.

    Recall: Z-0628-2007 · Initiated February 15, 2007

    Recall

    Recall Number
    Z-0628-2007
    Event Number
    37422
    Firm
    Merit Medical Systems, Inc
    FEI Number
    1721504
    Product Code
    KMK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 15, 2007
    Posted
    March 15, 2007
    Terminated
    November 9, 2011
    Address
    1600 West Merit Pkwy South, Jordan, UT, 84095-2416

    Description

    StayFix Fixation Device for Percutaneous catheters, REF 685ME, (large) 12F - 22F, Merit Medical, Unomedical, Ltd., Great Britain.

    Reason

    Sterility of some units may be compromised due to damaged packaging.

    Action

    Consignees were notified by letter on 02/23/2007. They were instructed to stop use of and return all affected product to Merit.

    Distribution

    Worldwide, including USA, France, Germany, and United Kingdom.

    Quantity

    51,584 units