BEUDAMED
    FDA Recall Terminated

    Irrisept OR, Finished Bottle Assembly 450 ml STEP 1

    Recall: Z-0490-2019 · Initiated September 5, 2017

    Recall

    Recall Number
    Z-0490-2019
    Event Number
    81399
    Firm
    Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
    FEI Number
    1417519
    Product Code
    FQH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 5, 2017
    Terminated
    September 23, 2024
    Address
    330 Corporate Woods Pkwy, Vernon Hills, IL, 60061-3107

    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.

    Action

    Firm sent recall notification letters to customers on 9/5/2017.

    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