BEUDAMED
    FDA Enforcement Class II Terminated

    Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079

    Recall: Z-1144-2018 · Reported March 28, 2018

    Enforcement

    Recall Number
    Z-1144-2018
    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-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079

    Reason

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

    Code Info

    Lot #: a) H1190448, Exp 7/31/2020, UDI (01)00884450328620(17)200731(10)H1190448; b) H1193585, Exp 5/30/2019, UDI (01)00884450328620(17)190530(10)H1193585

    Distribution

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

    Quantity

    44