BEUDAMED
    FDA Recall Terminated

    Merit MAK Mini Access Kit, 4 French (1.3mm)

    Recall: Z-1311-04 · Initiated July 20, 2004

    Recall

    Recall Number
    Z-1311-04
    Event Number
    29651
    Firm
    Merit Medical Systems, Inc
    FEI Number
    1721504
    Product Code
    DRE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 20, 2004
    Posted
    August 4, 2004
    Terminated
    January 21, 2005
    Address
    1600 Merit Pkwy South, Jordan, UT, 84095-2416

    Description

    Merit MAK Mini Access Kit, 4 French (1.3mm)

    Reason

    Firm received a report of an introducer sheath separating from its hub while in the patient. Surgery was successful in removal, even though the sheath kept breaking during the attempt.

    Action

    Consignees were notified by phone and letter on 7/20/2004.

    Distribution

    Nationwide, including VA facilities in MA, MI, NY, RI and TX. Argentina, Canada, China, Germany, Italy, Israel, Netherlands, New Zealand, Saudi Arabia, Scotland, Singapore, Thailand, United Arab Emirates.

    Quantity

    634 kits