BEUDAMED
    FDA Enforcement Class II Terminated

    Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024

    Recall: Z-2940-2020 · Reported September 16, 2020

    Enforcement

    Recall Number
    Z-2940-2020
    Event ID
    86163
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medical Components, Inc dba MedComp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 16, 2020
    Initiation Date
    July 27, 2020
    Classification Date
    September 6, 2020
    Termination Date
    April 30, 2021
    Address
    1499 Delp Dr, Harleysville, PA, 19438-2936, United States

    Description

    Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024

    Reason

    Kits were packaged with the incorrect size valve peelable introducer. The kits include a 15F instead of the correct 16F valve peelable introducer

    Code Info

    Lot # MPCT670, UDI 884908129304 Exp. Date 12/20/2020

    Distribution

    AZ, CA. FL. GA, NC, ND, NJ, NY, OH, PA, VA, WA

    Quantity

    132 eaches