BEUDAMED
    FDA Enforcement Class II 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 · Reported April 19, 2017

    Enforcement

    Recall Number
    Z-1766-2017
    Event ID
    76762
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merit Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 19, 2017
    Initiation Date
    March 3, 2017
    Classification Date
    April 10, 2017
    Termination Date
    June 21, 2017
    Address
    1600 W Merit Pkwy, N/A, South Jordan, UT, 84095-2416, United States

    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.

    Code Info

    Catalog Number: SRB24AC, Lot Numbers: H1068590S1, H1078177, H1078180, H1083628; Catalog Number: SRB24MED, Lot Numbers: H1068587S1,H1073974, H1078179, H1078181, H1083629, H1083630; Catalog Number: SRB29AC, Lot Numbers: H1068591S1, H1078183, H1083631; Catalog Number: SRB29MED, Lot Numbers: H1068589S1, H1078184, H1078185, H1083633.

    Distribution

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

    Quantity

    1,940 units total