BEUDAMED
    FDA Recall Terminated

    The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization procedures. It has a soft wristband with a secure hook and loop fastener. The band delivers adjustable compression of the puncture site with an inflatable bulb, and a check valve for easy inflation and deflation with a syringe. A clear curved backer plate provides optimal visualization of the puncture site and ease of placement.

    Recall: Z-1766-2017 · Initiated March 3, 2017

    Recall

    Recall Number
    Z-1766-2017
    Event Number
    76762
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    1721504
    Product Code
    DXC
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 3, 2017
    Posted
    April 10, 2017
    Terminated
    June 21, 2017
    Address
    1600 W Merit Pkwy South, Jordan, UT, 84095-2416

    Description

    The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization procedures. It has a soft wristband with a secure hook and loop fastener. The band delivers adjustable compression of the puncture site with an inflatable bulb, and a check valve for easy inflation and deflation with a syringe. A clear curved backer plate provides optimal visualization of the puncture site and ease of placement.

    Reason

    Merit Medical Systems, Inc. announces a voluntary field action for the PreludeSYNC Radial Compression Device because particulate generated during the manufacturing process may enter the valve, preventing a complete seal of the inflation valve.

    Action

    Merit Medical sent an Urgent Product Recall Notice on March 3, 2017, via letter for consignees to immediately stop using or distributing the affected lots and return them to Merit. For any questions, please contact Merit Customer Service at (801) 208-4381. For further questions regarding this recall, please call (801) 253-1600.

    Distribution

    Nationwide, Canadian and other foreign consignees. No VA/govt/military consignees.

    Quantity

    1,940 units total