BEUDAMED
    FDA Enforcement Class II Terminated

    Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078

    Recall: Z-1145-2018 · Reported March 28, 2018

    Enforcement

    Recall Number
    Z-1145-2018
    Event ID
    79426
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merit Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 28, 2018
    Initiation Date
    September 20, 2017
    Classification Date
    March 20, 2018
    Address
    1600 W Merit Pkwy, N/A, South Jordan, UT, 84095-2416, United States

    Description

    Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078

    Reason

    1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these dialysis kits.

    Code Info

    Lot #: H1190932, Exp 7/31/2020, UDI (01)00884450328613(17)200731(10)H1190932

    Distribution

    United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom

    Quantity

    8