BEUDAMED
    FDA Enforcement Class II Terminated

    MEDLINE PEDI ELBOW CLOSED SUCTION CATHETER, 8Fr, REF DYNCPE8

    Recall: Z-0112-2018 · Reported November 29, 2017

    Enforcement

    Recall Number
    Z-0112-2018
    Event ID
    78319
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medline Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 29, 2017
    Initiation Date
    October 10, 2017
    Classification Date
    November 18, 2017
    Termination Date
    August 4, 2020
    Address
    Three Lakes Drive, N/A, Northfield, IL, 60093, United States

    Description

    MEDLINE PEDI ELBOW CLOSED SUCTION CATHETER, 8Fr, REF DYNCPE8

    Reason

    Products labeled as sterile were distributed prior to sterilization

    Code Info

    Lot 2861707008

    Distribution

    FL, IN, TN, GA, NJ, UT, MD, Nicaragua, Honduras

    Quantity

    190 units