BEUDAMED
    FDA Enforcement Class II Terminated

    MEDLINE DOUBLE SWIVEL CLOSED SUCTION CATHETER, 21.3 in (54 cm) FOR ENDOTRACHEAL TUBE, 12 Fr, REF DYNCSDS12, 1 Each, Sterile

    Recall: Z-0113-2018 · Reported November 29, 2017

    Enforcement

    Recall Number
    Z-0113-2018
    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 DOUBLE SWIVEL CLOSED SUCTION CATHETER, 21.3 in (54 cm) FOR ENDOTRACHEAL TUBE, 12 Fr, REF DYNCSDS12, 1 Each, Sterile

    Reason

    Products labeled as sterile were distributed prior to sterilization

    Code Info

    Lot 28617070015

    Distribution

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

    Quantity

    120 units