BEUDAMED
    FDA Enforcement Class II Terminated

    Irrisept OR, Finished Bottle Assembly 450 ml STEP 1

    Recall: Z-0490-2019 · Reported November 28, 2018

    Enforcement

    Recall Number
    Z-0490-2019
    Event ID
    81399
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 28, 2018
    Initiation Date
    September 5, 2017
    Classification Date
    November 20, 2018
    Termination Date
    September 23, 2024
    Address
    330 Corporate Woods Pkwy, N/A, Vernon Hills, IL, 60061-3107, United States

    Description

    Irrisept OR, Finished Bottle Assembly 450 ml STEP 1

    Reason

    Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

    Code Info

    Model # FB-A-400-107 Lot Number: 4J006

    Distribution

    AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, and WI

    Quantity

    10,440