BEUDAMED
    FDA Enforcement Class II Terminated

    Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Contained within the tray are hand controller sheaths which are intended to enable increased flow control (when compared to hand injection) but with the feel of a hand syringe. It provides more control over the total volume delivered by allowing the physician to adjust contrast delivery during the injection and monitor total volume delivered to the patient.

    Recall: Z-1660-2013 · Reported July 10, 2013

    Enforcement

    Recall Number
    Z-1660-2013
    Event ID
    64078
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merit Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 10, 2013
    Initiation Date
    November 21, 2012
    Classification Date
    July 3, 2013
    Termination Date
    July 12, 2013
    Address
    12701 N Kingston Ave, N/A, Chester, VA, 23836-2700, United States

    Description

    Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Contained within the tray are hand controller sheaths which are intended to enable increased flow control (when compared to hand injection) but with the feel of a hand syringe. It provides more control over the total volume delivered by allowing the physician to adjust contrast delivery during the injection and monitor total volume delivered to the patient.

    Reason

    Custom Procedural trays contain Medrad Hand Controller Sheaths which were recalled because the seal between the white polyethylene and the clear plastic may be missing on the package resulting in a potential breach of the sterility of this accessory.

    Code Info

    Merit's Custom Angio kits K09T-09812B and K09T-09812C, Lot numbers T252244, T318352, T342249, T359185

    Distribution

    U.S. Military Hospital on base in Landstuhl, Germany

    Quantity

    134 trays