BEUDAMED
    FDA Enforcement Class II Terminated

    Mucus Specimen Trap 40 cc, Specimen Trap 40 cc with additional transport cap; Product number DYND44140 (pack of 50), Product number DYND44140H (individual). Mucus Specimen Trap 80 cc, Specimen Trap 80 cc w/ additional transport cap; Product number DYND44180 (pack of 50). Used to collect mucus specimens during suction of fluid from the oral cavity, nose-throat area and/or bronchi of a patient.

    Recall: Z-1612-2014 · Reported May 21, 2014

    Enforcement

    Recall Number
    Z-1612-2014
    Event ID
    66775
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medline Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 21, 2014
    Initiation Date
    November 4, 2013
    Classification Date
    May 13, 2014
    Termination Date
    November 29, 2017
    Address
    1 Medline Pl, Mundelein, IL, 60060-4485, United States

    Description

    Mucus Specimen Trap 40 cc, Specimen Trap 40 cc with additional transport cap; Product number DYND44140 (pack of 50), Product number DYND44140H (individual). Mucus Specimen Trap 80 cc, Specimen Trap 80 cc w/ additional transport cap; Product number DYND44180 (pack of 50). Used to collect mucus specimens during suction of fluid from the oral cavity, nose-throat area and/or bronchi of a patient.

    Reason

    There is a potential that the specified mucus specimen traps are not sterile. Use of the affected products may result in the contamination of patient specimens.

    Code Info

    Model Numbers: DYND44140, DYND44140H, and DYND44180; Purchase Order Number: 4506595929

    Distribution

    US Nationwide Distribution in the states of CA, MA, MD, MI, MN, NH, NJ, NY, OH, PA, TX, and UT.

    Quantity

    1,610 mucus specimen traps