BEUDAMED
    FDA Enforcement Class II Terminated

    8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyurethane Catheter

    Recall: Z-1271-2018 · Reported April 4, 2018

    Enforcement

    Recall Number
    Z-1271-2018
    Event ID
    79445
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medical Components, Inc dba MedComp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 4, 2018
    Initiation Date
    November 22, 2017
    Classification Date
    March 29, 2018
    Termination Date
    July 11, 2018
    Address
    1499 Delp Dr, Harleysville, PA, 19438-2936, United States

    Description

    8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyurethane Catheter

    Reason

    The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked guidewire. The kits were packaged with an unmarked guidewire.

    Code Info

    Lot/Serial/Model/Catalog Numbers/Exp. Date: Lot # MJKK420; serial # N/A, Catalog # MRDP80PLN, Exp. Date 2022-01-09; UDI#- 884908110449

    Distribution

    CA, AR. AL

    Quantity

    24 Eaches