BEUDAMED
    FDA Enforcement Class II Terminated

    Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical.

    Recall: Z-1404-2015 · Reported April 15, 2015

    Enforcement

    Recall Number
    Z-1404-2015
    Event ID
    70723
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 15, 2015
    Initiation Date
    March 13, 2015
    Classification Date
    April 8, 2015
    Termination Date
    August 14, 2017
    Address
    2917 Weck Dr, N/A, Research Triangle Park, NC, 27709-0186, United States

    Description

    Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical.

    Reason

    Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant sized chest drainage system.

    Code Info

    Catalogue no. S-1100-08LF, Lot no. 74F1400878

    Distribution

    US Distribution to the states of : AK, AL, AR, CA, CO, FL, GA, IL, IN, KY, KS, MA, MD, MI, MN, NY, OH, PA, RI, SC, TX, VA WI and WV.

    Quantity

    2,148 units