BEUDAMED
    FDA Enforcement Class II Terminated

    KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.

    Recall: Z-1222-2015 · Reported March 11, 2015

    Enforcement

    Recall Number
    Z-1222-2015
    Event ID
    70397
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Halyard Health
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 11, 2015
    Initiation Date
    January 16, 2015
    Classification Date
    February 27, 2015
    Termination Date
    July 7, 2015
    Address
    1400 Holcomb Bridge Rd, N/A, Roswell, GA, 30076-2190, United States

    Description

    KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.

    Reason

    Defect: A hole or crack was found which may cause air to leak.

    Code Info

    Product Code; 22108147, Wet Pak Lot number: AB4195U14, AB4216U06 & AB4230U16, KimVent Lot Number: M4132T643.

    Distribution

    CA, FL, IL, LA, MA, MK, MN, MS, NM, NY, OK and TX and Japan.

    Quantity

    83 cases (20 tubes per case)